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FDA Approvals of Brand-Name Prescription Drugs, January 1, 2019, Through June 15, 2020

August 2020 Vol 13, Eleventh Annual Payers' Guide - FDA Approvals

The drugs included in this review were approved for the first time or received additional approvals by the US Food and Drug Administration between January 1, 2019, and June 15, 2020, and are grouped here by several categories:

I. New Molecular Entities and New Biologic License Applications (NMEs and BLAs)
II. New Gene Therapies, Vaccines, and Blood Products
III. New Indications and New Combinations
IV. New Dosages, Dosage Strengths, Formulations, and Patient Populations
V. New Biosimilars

I. New Molecular Entities and New Biologic License Applications

Accrufer (NME)
(Ferric malto; Shield Therapeutics)
Class/route: Iron replacement; oral capsule
Indication: Treatment of iron deficiency in adults
Approval date: July 25, 2019

Adakveo (BLA)
(Crizanlizumab-tmca; Novartis)
Class/route: First-in-class immunoglobulin G2 kappa monoclonal antibody; intravenous injection
Indication: To reduce the frequency of vaso-occlusive crises in patients aged ≥16 years with sickle-cell disease
Approval considerations: Breakthrough therapy, orphan drug, priority review
Approval date: November 15, 2019

Aklief (NME)
(Trifarotene; Galderma Laboratories)
Class/route: Retinoid; topical cream
Indication: Topical treatment of acne vulgaris in patients aged ≥9 years
Approval date: October 4, 2019

Artesunate (NME)
(Artesunate; Amivas)
Class/route: Antimalarial agent; intravenous injection
Indication: Initial treatment of severe malaria in adult and pediatric patients
Limitations of use: Artesunate for injection does not treat the hypnozoite liver stage forms of Plasmodium and will therefore not prevent relapses of malaria caused by P vivax or P ovale. Concomitant therapy with an anti­malarial agent is necessary for severe malaria caused by P vivax or P ovale
Approval considerations: Orphan drug, priority review
Approval date: May 26, 2020

Ayvakit (NME)
(Avapritinib; Blueprint Medicines)
Class/route: Tyrosine kinase inhibitor; oral tablets
Indication: Treatment of adults with unresectable or metastatic gastrointestinal stromal tumor harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: January 9, 2020

Balversa (NME)
(Erdafitinib; Janssen Biotech)
Class/route: First-in-class FGFR kinase inhibitor; oral tablet
Indication: Treatment of adults with locally advanced or metastatic urothelial carcinoma and susceptible FGFR2 or FGFR3 gene alterations that progressed during or after ≥1 lines of platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-­containing chemotherapy
Approval considerations: Accelerated approval, breakthrough therapy, priority review
Approval date: April 12, 2019

Barhemsys (NME)
(Amisulpride; Acacia Pharma Group)
Class/route: Dopamine-2 antagonist; intravenous injection
Indications: Prevention of postoperative nausea and vomiting, as monotherapy or in combination with an antiemetic of a different class; treatment of postoperative nausea and vomiting, regardless of any previous ­antiemetic prophylaxis
Approval date: February 26, 2020

Beovu (BLA)
(Brolucizumab-dbll; Novartis)
Class/route: VEGF factor A inhibitor; intravitreal injection
Indication: Treatment of neovascular (wet) age-related macular degeneration
Approval date: October 7, 2019

Brukinsa (NME)
(Zanubrutinib; BeiGene)
Class/route: Bruton tyrosine kinase inhibitor; oral capsules
Indication: Treatment of mantle-cell lymphoma in adults after ≥1 previous therapies
Approval considerations: Accelerated approval, breakthrough therapy, orphan drug, priority review
Approval date: November 14, 2019

Cablivi (BLA)
(Caplacizumab-yhdp; Ablynx)
Class/routes: First-in-class von Willebrand factor–directed antibody fragment; intravenous or subcutaneous injection
Indication: Treatment of adults with acquired thrombo­tic thrombocytopenic purpura, in combination with plasma exchange and immunosuppressive therapy
Approval considerations: Fast track, orphan drug, priority review
Approval date: February 6, 2019

Caplyta (NME)
(Lumateperone; Intra-Cellular Therapies)
Class/route: Atypical antipsychotic; oral capsules
Indication: Treatment of schizophrenia in adults
Approval consideration: Fast track
Approval date: December 20, 2019

Cerianna (NME)
(Fluoroestradiol F 18; PETNET Solutions)
Class/route: Radioactive diagnostic agent; intravenous injection
Indication: For use with PET imaging for detection of ER-positive lesions, as an adjunct to biopsy in patients with recurrent or metastatic breast cancer
Limitations of use: Tissue biopsy should be used to confirm breast cancer recurrence and to verify ER status by pathology. Cerianna is not useful for imaging other receptors
Approval date: May 20, 2020

Dayvigo (NME)
(Lemborexant; Eisai)
Class/route: Orexin receptor antagonist; oral tablets
Indication: Treatment of insomnia in adults
Approval date: December 20, 2019

Egaten (NME)
(Triclabendazole; Novartis)
Class/route: Anthelmintic; oral tablets
Indication: Treatment of fascioliasis in patients aged ≥6 years
Approval considerations: Fast track, orphan drug, priority review
Approval date: February 13, 2019

Enhertu (BLA)
(Fam-trastuzumab deruxtecan-nxki; Daiichi Sankyo)
Class/route: HER2-directed antibody and topoisomerase inhibitor conjugate; intravenous injection
Indication: Treatment of adults with unresectable or metastatic HER2-positive breast cancer after ≥2 anti–HER2-based regimens in the metastatic setting
Approval considerations: Accelerated approval, breakthrough therapy, fast track, priority review
Approval date: December 20, 2019

Evenity (BLA)
(Romosozumab-aqqg; Amgen)
Class/route: First-in-class sclerostin inhibitor; subcutaneous injection
Indication: Treatment of osteoporosis in postmenopausal women at high risk or with multiple risk factors for fracture, or in patients who did not respond to or are intolerant of other osteoporosis therapies
Limitations of use: Limit duration of use to 12 monthly doses
Approval date: April 9, 2019

ExEm Foam (NME)
(Air polymer-type A; ExEm Foam)
Class/route: Ultrasound contrast agent; intrauterine foam
Indication: For sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility
Approval date: November 7, 2019

Fetroja (NME)
(Cefiderocol; Shionogi)
Class/route: Cephalosporin antibacterial; intravenous injection
Indication: Treatment of complicated urinary tract infections, including pyelonephritis caused by susceptible Gram-negative microorganisms, in patients aged ≥18 years who have limited or no alternative treatment options
Approval considerations: Fast track, QIDP, priority ­review
Approval date: November 14, 2019

Fluorodopa F 18a (NME)
(Fluorodopa F 18 injection; The Feinstein Institutes for Medical Research)
Class/route: Radioactive diagnostic agent; intravenous injection
Indication: Evaluation of adults with suspected Parkinsonian syndromes, for use with PET to visualize dopaminergic nerve terminals in the striatum
Approval date: October 10, 2019

Ga 68 DOTATOCa (NME)
(Gallium DOTATOC GA 68 injection; UIHC-P E T Imaging Center)
Class/route: Radioactive diagnostic agent; intravenous injection
Indication: Localization of somatostatin receptor–positive neuroendocrine tumors in adults and pediatric patients, for use with PET
Approval consideration: Orphan drug
Approval date: August 21, 2019

Givlaari (NME)
(Givosiran; Alnylam Pharmaceuticals)
Class/route: First-in-class aminolevulinate synthase 1-­directed small interfering RNA; subcutaneous injection
Indication: Treatment of acute hepatic porphyria in adults
Approval considerations: Breakthrough therapy, orphan drug, priority review
Approval date: November 20, 2019

Ibsrela (NME)
(Tenapanor; Ardelyx)
Class/route: First-in-class sodium/hydrogen exchanger 3 inhibitor; oral tablets
Indication: Treatment of adults with irritable bowel ­syndrome and constipation
Approval date: September 12, 2019

Inrebic (NME)
(Fedratinib; Impact Biomedicines)
Class/route: Multikinase inhibitor; oral capsules
Indication: Treatment of intermediate-2 or high-risk ­primary or secondary (post–polycythemia vera or post­essential thrombocythemia) myelofibrosis in adults
Approval considerations: Orphan drug, priority review
Approval date: August 16, 2019

Isturisa (NME)
(Osilodrostat; Novartis)
Class/route: First-in-class cortisol synthesis inhibitor; oral tablets
Indication: Treatment of Cushing’s disease in adults for whom pituitary surgery is not an option or has not been curative
Approval consideration: Orphan drug
Approval date: March 6, 2020

Jelmyto (NME)
(Mitomycin; UroGen Pharma)
Class/route: First-in-class alkylating drug; pyelocalyceal solution
Indication: Treatment of low-grade upper tract urothelial cancer in adults
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: April 15, 2020

Jeuveau (BLA)
(PrabotulinumtoxinA-xvfs; Evolus)
Class/route: Acetylcholine release inhibitor and neuromuscular-blocking agent; intramuscular injection
Indication: Temporary improvement in the appearance of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity in adults
Approval date: February 1, 2019

Koselugo (NME)
(Selumetinib; AstraZeneca)
Class/route: Mitogen-activated protein kinase inhibitor; oral capsules
Indication: Treatment of patients aged ≥2 years with neurofibromatosis type 1 who have symptomatic, in­operable plexiform neurofibromas
Approval considerations: Breakthrough therapy, orphan drug, priority review
Approval date: April 10, 2020

Mayzent (NME)
(Siponimod; Novartis)
Class/route: Sphingosine 1-phosphate receptor modulator; oral tablets
Indication: Treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Approval consideration: Priority review
Approval date: March 26, 2019

Nexletol (NME)
(Bempedoic acid; Esperion Therapeutics)
Class/route: First-in-class adenosine triphosphate-citrate lyase inhibitor; oral tablets
Indication: Treatment of heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease, as an adjunct to diet and maximally tolerated statin therapy, in adults who require additional lowering of low-density lipoprotein cholesterol
Limitations of use: The effect of Nexletol on cardiovascular morbidity and mortality has not been determined
Approval date: February 21, 2020

Nourianz (NME)
(Istradefylline; Kyowa Kirin)
Class/route: First-in-class adenosine receptor antagonist; oral tablets
Indication: Adjunctive treatment to levodopa plus carbidopa in adults with Parkinson’s disease who are having “off” episodes
Approval date: August 27, 2019

Nubeqa (NME)
(Darolutamide; Bayer Healthcare)
Class/route: Androgen receptor inhibitor; oral tablets
Indication: Treatment of nonmetastatic castration-resistant prostate cancer
Approval considerations: Fast track, priority review
Approval date: July 30, 2019

Nurtec OTD (NME)
(Rimegepant; Biohaven)
Class/route: First-in-class calcitonin gene-related peptide receptor antagonist; sublingual or orally disintegrating tablets
Indication: For acute treatment of migraine with or without aura in adults
Limitations of use: Not indicated for the prevention of migraine
Approval consideration: Priority review
Approval date: February 27, 2020

Ongentys (NME)
(Opicapone; Neurocrine Biosciences)
Class/route: Catechol-O-methyltransferase inhibitor; oral capsules
Indication: As adjunctive treatment to levodopa plus carbidopa, in patients with Parkinson’s disease who are having “off” episodes
Approval date: April 24, 2020

Oxbryta (NME)
(Voxelotor; Global Blood Therapeutics)
Class/route: First-in-class hemoglobin S polymerization inhibitor; oral tablets
Indication: Treatment of sickle-cell disease in patients aged ≥12 years
Approval considerations: Accelerated approval, breakthrough therapy, fast track, orphan drug, priority review
Approval date: November 25, 2019

Padcev (BLA)
(Enfortumab vedotin-ejfv; Astellas Pharma)
Class/route: First-in-class nectin-4–directed antibody and microtubule inhibitor conjugate; intravenous injection
Indication: Treatment of locally advanced or metastatic urothelial cancer in adults who have previously received a PD-1 or PD-L1 inhibitor, and a platinum-­containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting
Approval considerations: Accelerated approval, breakthrough therapy, priority review
Approval date: December 18, 2019

Palforzia (BLA)
(Peanut [Arachis hypogaea] Allergen Powder-dnfp; Aimmune Therapeutics)
Class/route: Oral immunotherapy; oral powder
Indication: Mitigation of peanut allergies, including anaphylaxis, in patients aged ≥4 years with confirmed peanut allergies, for use with peanut-avoidance diet
Limitations of use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis
Approval consideration: REMS
Approval date: January 31, 2020

Pemazyre (NME)
(Pemigatinib; Incyte)
Class/route: FGFR inhibitor; oral tablets
Indication: Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma and an FGFR2 fusion or other rearrangements, as identified by an FDA-approved test
Approval considerations: Accelerated approval, breakthrough therapy, orphan drug, priority review
Approval date: April 17, 2020

Piqray (NME)
(Alpelisib; Novartis)
Class/route: PI3K inhibitor; oral tablet
Indication: Treatment, in combination with fulvestrant, of postmenopausal women, and men, with HR-positive, HER2-negative, advanced or metastatic breast cancer and PIK3CA mutation, as detected by an FDA-­approved test, after disease progression during or after an endocrine-based regimen
Approval considerations: Priority review, Real-Time ­Oncology Review
Approval date: May 24, 2019

Pizensy (NME)
(Lactitol; Braintree Laboratories)
Class/route: Osmotic laxative; oral solution
Indication: Treatment of chronic idiopathic constipation in adults
Approval date: February 12, 2020

Polivy (BLA)
(Polatuzumab vedotin-piiq; Genentech)
Class/route: First-in-class CD79b-directed antibody–drug conjugate; intravenous injection
Indication: Treatment, in combination with bendamustine and rituximab, of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, after ≥2 therapies
Approval considerations: Accelerated approval, breakthrough therapy, orphan drug, priority review
Approval date: June 10, 2019

Pretomanida (NME)
(Pretomanid; TB Alliance)
Class/route: First-in-class antimycobacterial agent; oral tablets
Indication: Treatment, in combination with bedaquiline and linezolid, of pulmonary extensively drug-resistant, treatment-intolerant or nonresponsive multidrug-­resistant tuberculosis in adults
Limitations of use: Not indicated for patients with drug-sensitive tuberculosis, latent infection resulting from Mycobacterium tuberculosis, extrapulmonary infection resulting from M tuberculosis, or multidrug-resistant tuberculosis that is not treatment-intolerant or nonresponsive to standard therapy
Approval considerations: Fast track, limited Population Pathway for Antibacterial and Antifungal Drugs, ­orphan drug, priority review, QIDP
Approval date: August 14, 2019

Qinlock (NME)
(Ripretinib; Deciphera)
Class/route: Tyrosine kinase inhibitor; oral tablets
Indication: Treatment of advanced gastrointestinal stromal tumor in adults, after treatment with ≥3 kinase inhibitors, including imatinib
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: May 15, 2020

Reblozyl (BLA)
(Luspatercept-aamt; Celgene)
Class/route: First-in-class erythroid maturation agent; subcutaneous injection
Indication: Treatment of anemia in adults with beta-­thalassemia who require regular red blood cell transfusions
Approval considerations: Fast track, orphan drug, priority review
Approval date: November 8, 2019

Recarbrio (NME)
(Imipenem, cilastatin, and relebactam; Merck)
Classes/route: Penem antibacterial, renal dehydro­peptidase inhibitor, and beta-lactamase inhibitor; ­intravenous injection
Indication: Treatment of complicated urinary tract infections, including pyelonephritis, and complicated intra-­abdominal infections, caused by susceptible Gram-­negative bacteria, in patients aged ≥18 years who have limited or no alternative treatment options
Approval considerations: Fast track, priority review, QIDP
Approval date: July 16, 2019
See also New Indications and New Combinations listing

Retevmo (NME)
(Selpercatinib; Loxo Oncology)
Class/route: RET kinase inhibitor; oral capsules
Indications: Treatment of adults with metastatic NSCLC and RET fusion; treatment of advanced or metastatic medullary thyroid cancer with RET mutation in patients aged ≥12 years who require systemic therapy; treatment of advanced or metastatic thyroid cancer and RET fusion in patients aged ≥12 years who require systemic therapy and have radioactive iodine–refractory cancer, if treatment with radioactive iodine is appropriate
Approval considerations: Accelerated approval, breakthrough therapy, orphan drug, priority review
Approval date: May 8, 2020

Reyvow (NME)
(Lasmiditan; Eli Lilly)
Class/route: First-in-class serotonin 5-HT 1F receptor agonist; oral tablets
Indication: Treatment of acute migraine, with or without aura, in adults
Limitations of use: Not indicated for the prevention of migraine
Approval date: October 11, 2019

Rinvoq (NME)
(Upadacitinib; AbbVie)
Class/route: JAK inhibitor; oral extended-release tablets
Indication: Treatment of moderate-to-severe rheumatoid arthritis in adults who have had an inadequate response to or are intolerant of methotrexate
Limitations of use: Not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants, such as azathioprine and cyclosporine
Approval consideration: Priority review
Approval date: August 16, 2019

Rozlytrek (NME)
(Entrectinib; Genentech)
Class/route: Selective tyrosine kinase inhibitor; oral capsules
Indications: Treatment of adults with metastatic NSCLC and ROS1 mutation; treatment of patients aged ≥12 years with solid tumors and NTRK gene fusion, without an acquired resistance mutation, that are metastatic or ineligible for resection in patients who have no alternative treatment
Approval considerations: Accelerated approval, breakthrough therapy, orphan drug, priority review
Approval date: August 15, 2019

Sarclisa (BLA)
(Isatuximab-irfc; Sanofi Aventis)
Class/route: CD38-directed cytolytic antibody; intravenous injection
Indication: Treatment, in combination with pomalidomide and dexamethasone, of adults with multiple myeloma, after ≥2 therapies, including lenalidomide and a proteasome inhibitor
Approval consideration: Orphan drug
Approval date: March 2, 2020

Scenesse (NME)
(Afamelanotide; Clinuvel Pharmaceuticals)
Class/route: First-in-class elanocortin 1 receptor agonist; subcutaneous implant
Indication: To increase pain-free light exposure in adults with a history of phototoxic reactions from erythro­poietic protoporphyria
Approval considerations: Fast track, orphan drug, priority review
Approval date: October 8, 2019

Skyrizi (BLA)
(Risankizumab-rzaa; AbbVie)
Class/route: IL-23 antagonist; subcutaneous injection
Indication: Treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
Approval date: April 23, 2019

Spravato (NME)
(Esketamine; Janssen)
Class/route: Noncompetitive N-methyl D-aspartate ­receptor antagonist; nasal spray
Indications: Treatment, in conjunction with an oral antidepressant, for treatment-resistant depression in adults (on August 3, 2020, esketamine was approved for treatment of depressive symptoms in adults with major depressive disorder and acute suicidal ideation or behavior)
Limitations of use: The effectiveness of esketamine in the prevention of suicide or in the reduction of suicidal ideation or behavior has not been demonstrated; use of esketamine does not preclude the need for hospitalization if clinically warranted, even if patients improve after an initial dose of esketamine; esketamine is not approved as an anesthetic agent; the safety and effectiveness of esketamine as an anesthetic agent have not been established
Approval considerations: Breakthrough therapy, fast track, REMS
Approval date: March 5, 2019

Sunosi (NME)
(Solriamfetol; Jazz Pharmaceuticals)
Class/route: First-in-class dopamine and norepinephrine reuptake inhibitor; oral tablets
Indication: To improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or with obstructive sleep apnea
Limitations of use: Not indicated for treatment of underlying airway obstruction in obstructive sleep apnea
Approval consideration: Orphan drug
Approval date: March 20, 2019

Tabrecta (NME)
(Capmatinib; Novartis)
Class/route: MET kinase inhibitor; oral tablets
Indication: Treatment of adults with metastatic NSCLC whose tumors have a mutation that leads to MET exon 14 skipping, as detected by an FDA-approved test
Approval considerations: Accelerated approval, breakthrough therapy, orphan drug, priority review
Approval date: May 6, 2020

Tauvid (NME)
(Flortaucipir F 18 injection; Avid Radiopharmaceuticals)
Class/route: Radioactive diagnostic agent; intravenous injection
Indication: Diagnostic agent for PET imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles in adults with cognitive impairment who are being evaluated for Alzheimer’s disease
Limitations of use: Not indicated for evaluation of patients for chronic traumatic encephalopathy
Approval consideration: Priority review
Approval date: May 28, 2020

Tazverik (NME)
(Tazemetostat; Epizyme)
Class/route: First-in-class methyltransferase inhibitor; oral tablet
Indication: Treatment of patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma who are ineligible for complete resection
Approval considerations: Accelerated approval, orphan drug, priority review
Approval date: January 23, 2020

Tepezza (BLA)
(Teprotumumab-trbw; Horizon Therapeutics Ireland)
Classes/route: Monoclonal antibody and insulin-like growth factor-1 receptor inhibitor; intravenous injection
Indication: Treatment of thyroid eye disease
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: January 21, 2020

TissueBlue (NME)
(Brilliant blue G ophthalmic solution; Dutch Ophthalmic)
Class/route: Disclosing agent; intraocular
Indication: Disclosing agent to stain the internal limiting membrane selectively
Approval considerations: Accelerated approval, orphan drug, priority review
Approval date: December 20, 2019

Trikafta (NME)
(Elexacaftor, tezacaftor, and ivacaftor; Vertex)
Class/route: 2 CFTR correctors and CFTR potentiator; oral tablets
Indication: Treatment of cystic fibrosis in patients aged ≥12 years who have ≥1 F508del CFTR mutations
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: October 21, 2019
See also New Indications and New Combinations listing

Trodelvy (BLA)
(Sacituzumab govitecan-hziy; Immunomedics)
Classes/route: First-in-class trop-2–directed antibody and topoisomerase inhibitor conjugate; intravenous injection
Indication: Treatment of adults with metastatic triple-­negative breast cancer after ≥2 therapies for metastatic disease
Approval considerations: Accelerated approval, breakthrough therapy, priority review
Approval date: April 22, 2020

Tukysa (NME)
(Tucatinib; Seattle Genetics)
Class/route: Tyrosine kinase inhibitor; oral tablet
Indication: Treatment, in combination with trastuzumab and capecitabine, of advanced unresectable or metasta­tic HER2-positive breast cancer in adults, including patients with brain metastases, after ≥1 anti–HER2-based regimens in the metastatic setting
Approval considerations: Breakthrough therapy, orphan drug, priority review
Approval date: April 17, 2020

Turalio (NME)
(Pexidartinib; Daiichi Sankyo)
Class/route: First-in-class tyrosine kinase inhibitor; oral capsules
Indication: Treatment of adults with symptomatic tenosynovial giant-cell tumor associated with severe morbidity or functional limitations that will not improve with surgery
Approval considerations: Breakthrough therapy, orphan drug, priority review, REMS
Approval date: August 2, 2019

Ubrelvy (NME)
(Ubrogepant; Allergan)
Class/route: Calcitonin gene–related peptide receptor antagonist; oral tablets
Indication: Treatment of adults with acute migraine, with or without aura
Limitations of use: Not indicated for the prevention of migraine
Approval date: December 23, 2019

Uplizna (BLA)
(Inebilizumab-cdon; Viela Bio)
Class/route: CD19-directed cytolytic antibody; intravenous injection
Indication: Treatment of adults with neuromyelitis optica spectrum disorder and anti–aquaporin-4 antibody
Approval consideration: Orphan drug
Approval date: June 11, 2020

Vyepti (BLA)
(Eptinezumab-jjmr; H. Lundbeck A/S)
Class/route: Calcitonin gene-related peptide antagonist; intravenous injection
Indication: Prevention of migraine in adults
Approval date: February 21, 2020

Vyleesi (NME)
(Bremelanotide; AMAG Pharmaceuticals)
Class/route: First-in-class melanocortin receptor agonist; subcutaneous injection
Indication: Treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder as characterized by low sexual desire that causes marked distress or interpersonal difficulty and does not result from a coexisting medical or psychiatric condition, problems with the relationship, or the effects of a medication or drug substance
Limitations of use: Not indicated for treatment of hypoactive sexual desire disorder in postmenopausal women or in men or to enhance sexual performance
Approval date: June 21, 2019

Vyndamax (NME)
(Tafamidis; FoldRx/Pfizer)
Class/route: First-in-class transthyretin stabilizer; oral capsules
Indication: Treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: May 3, 2019

Vyndaqel (NME)
(Tafamidis meglumine; FoldRx/Pfizer)
Class/route: First-in-class transthyretin stabilizer; oral capsules
Indication: Treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: May 3, 2019

Vyondys 53 (NME)
(Golodirsen; Sarepta Therapeutics)
Class/route: Antisense oligonucleotide; intravenous injection
Indication: Treatment of Duchenne muscular dystrophy in patients with a confirmed DMD gene mutation that is amenable to exon 53 skipping
Approval considerations: Accelerated approval, fast track, orphan drug, priority review
Approval date: December 12, 2019

Wakix (NME)
(Pitolisant; Harmony Biosciences)
Class/route: First-in-class histamine-3 receptor antagonist/inverse agonist; oral tablets
Indication: Treatment of excessive daytime sleepiness in adults with narcolepsy
Approval considerations: Fast track, orphan drug, priority review
Approval date: August 14, 2019

Xcopri (NME)
(Cenobamate; SK Life Science)
Class/route: Antiepileptic drug; oral tablets
Indication: Treatment of partial-onset seizures in adults
Approval date: November 21, 2019

Xenleta (NME)
(Lefamulin; Nabriva Therapeutics)
Class/routes: Pleuromutilin antibacterial; intravenous injection, oral tablets
Indication: Treatment of community-acquired bacterial pneumonia resulting from susceptible microorganisms in adults
Approval considerations: Fast track, priority review, QIDP
Approval date: August 19, 2019

Xpovio (NME)
(Selinexor; Karyopharm Therapeutics)
Class/route: First-in-class nuclear export inhibitor; oral tablets
Indication: Treatment, in combination with dexamethasone, of relapsed or refractory multiple myeloma, after ≥4 therapies, in adults whose disease is refractory to ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-CD38 monoclonal antibody
Approval considerations: Accelerated approval, fast track, orphan drug, priority review
Approval date: July 3, 2019

Zeposia (NME)
(Ozanimod; Bristol Myers Squibb)
Class/route: Sphingosine 1-phosphate receptor modulator; oral capsules
Indication: Treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Approval date: March 25, 2020

Zepzelca (NME)
(Lurbinectedin; Pharma Mar)
Class/route: Alkylating drug; intravenous injection
Indication: Treatment of adults with metastatic small-cell lung cancer whose disease progressed during or after platinum-based chemotherapy
Approval consideration: Accelerated approval
Approval date: June 15, 2020

Zulresso (NME)
(Brexanolone; Sage Therapeutics)
Class/route: First-in-class neuroactive steroid gamma-­aminobutyric acid A receptor–positive modulator; intravenous injection
Indication: Treatment of postpartum depression in adults
Approval considerations: Breakthrough therapy, priority review, REMS
Approval date: March 19, 2019

 

aDrug approved without trade name.
CFTR indicates cystic fibrosis transmembrane conductance regulator; DMARDs, disease-modifying antirheumatic drugs; ER, estrogen receptor; FDA, US Food and Drug Administration; FGFR, fibroblast growth factor receptor; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IL, interleukin; JAK, Janus kinase;
MET, mesenchymal-epithelial transition; NSCLC, non–small-cell lung cancer; NTRK, neurotrophic receptor tyrosine kinase; PD-1, programmed cell-death receptor 1; PDGFRA, platelet-derived growth factor receptor alpha;
PD-L1, programmed cell-death ligand 1; PET, positron emission tomography; PI3K, phosphatidylinositol 3-kinase; QIDP, Qualified Infectious Disease Product; REMS, Risk Evaluation and Mitigation Strategy; RNA, ribonucleic acid; VEGF, vascular endothelial growth factor.


II. New Gene Therapies, Vaccines, and Blood Products

Asceniv (new blood product)
(Immune globulin intravenous, [human]-slra, 10% liquid; ADMA Biologics)
Class/route: Immune globulin intravenous, human; 10% immune globulin liquid for intravenous injection
Indication: Treatment of primary humoral immunodeficiency in patients aged ≥12 years
Approval date: April 1, 2019

Audenz (new vaccine)
(Influenza A [H5N1] monovalent vaccine, adjuvanted; Seqirus)
Class/route: Vaccine; intramuscular injection
Indication: Prevention of influenza A virus H5N1 subtype contained in the vaccine, for persons aged ≥6 months
Approval consideration: Fast track
Approval date: January 31, 2020

Dengvaxia (new vaccine)
(Dengue tetravalent vaccine, live; Sanofi Pasteur)
Class/route: Vaccine; subcutaneous injection
Indication: Prevention of dengue disease that results from dengue virus serotypes 1-4
Limitations of use: Not approved for use in individuals without previous infection with any dengue virus serotype or for whom this information is unknown; the safety and effectiveness of dengue tetravalent vaccine have not been established in individuals living in dengue nonendemic areas who travel to dengue endemic areas
Approval date: May 1, 2019

Ervebo (new vaccine)
(Ebola Zaire vaccine, live; Merck Sharp & Dohme)
Class/route: Vaccine; intramuscular injection
Indication: First vaccine for the prevention of Zaire ­ebolavirus in patients aged ≥18 years
Limitations of use: The duration of protection conferred by Ebola Zaire vaccine is unknown; this vaccine does not protect against other species of Ebolavirus or Marburgvirus; the effectiveness of the vaccine, when administered concurrently with antiviral medication, immune globulin, and/or blood or plasma transfusions, is unknown
Approval considerations: Breakthrough therapy, priority review, tropical disease priority review voucher
Approval date: December 19, 2019

Esperdoct (new blood product)
(Antihemophilic factor [recombinant], glycopegylated-­exei; Novo Nordisk)
Class/route: Coagulation factor VIII concentrate; lyophilized powder for solution administered as intravenous infusion
Indication: On-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce bleeding episodes in adults and children with hemophilia A
Limitations of use: Not indicated for treatment of von Willebrand disease
Approval date: February 19, 2019

Jynneos (new vaccine)
(Smallpox and monkeypox vaccine, live, nonreplicating; Bavarian Nordic A/S)
Class/route: Vaccine; subcutaneous injection
Indication: Prevention of smallpox and monkeypox in adults aged ≥18 years who are at high risk for smallpox or monkeypox infection
Approval consideration: Priority review
Approval date: September 24, 2019

MenQuadfi (new vaccine)
(Meningococcal [groups A, C, Y, W] conjugate vaccine; Sanofi Pasteur)
Class/route: Vaccine; intramuscular injection
Indication: Active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y in individuals aged ≥2 years
Approval date: April 23, 2019

Sevenfact (new blood product)
(Coagulation factor VIIa [recombinant]-jncw; Laboratoire Français du Fractionnement et des Biotechnologies S.A.)
Class/route: Coagulation factor VIIa concentrate; lyophilized powder for reconstitution for intravenous use
Indication: Treatment and control of bleeding episodes in patients aged ≥12 years with hemophilia A or B with inhibitors
Limitations of use: Not indicated for treatment of congenital factor VII deficiency
Approval date: April 27, 2020

Xembify (new blood product)
(Immune globulin subcutaneous, human-klhw, 20%; Grifols Therapeutics)
Class/route: Human immune globulin protein; 20% immune globulin solution for subcutaneous injection
Indication: Treatment of patients aged ≥2 years with primary humoral immunodeficiency
Approval date: July 3, 2019

Zolgensma (new gene therapy)
(Onasemnogene abeparvovec-xioi; AveXis)
Class/route: Adeno-associated virus vector-based gene therapy; intravenous infusion
Indication: Treatment of pediatric patients aged <2 years with spinal muscular atrophy and a bi-allelic SMN1 gene mutation
Limitations of use: The safety and effectiveness of repeat administration of onasemnogene abeparvovec have not been evaluated, and its use in patients with advanced spinal muscular atrophy has not been evaluated
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: May 24, 2019

 

SMN1 indicates survival motor neuron 1.


III. New Indications and New Combinations

Alunbrig (new indication)
(Brigatinib; Takeda)
Class/route: Tyrosine kinase inhibitor; oral tablets
New Indication: First-line treatment of patients with NSCLC and ALK mutation, as detected by an FDA-­approved test
Existing Indication: Treatment of patients with NSCLC and ALK mutation whose disease progressed during crizotinib therapy or who are intolerant of crizotinib
Approval date: May 22, 2020

Bavencio (new indication)
(Encorafenib; Array BioPharma)
Class/route: RAF kinase inhibitor; oral capsules
New Indication: Second-line treatment, in combination with cetuximab, of metastatic colorectal cancer in adults with a BRAF V600E mutation, as detected by an FDA-­approved test
Existing Indications: Treatment, in combination with bin­imetinib, of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
Limitations of use: Not indicated for wild-type BRAF melanoma or wild-type BRAF colorectal cancer
Approval considerations: Breakthrough therapy, priority review
Approval date: April 8, 2020

BRAFtovi (new indication)
(Avelumab; EMD Serono)
Class/route: PD-L1 inhibitor; intravenous injection
New Indication: First-line treatment, in combination with axitinib, of advanced renal-cell carcinoma
Existing Indications: Treatment of metastatic Merkel-cell carcinoma; maintenance treatment of locally advanced or metastatic urothelial carcinoma
Approval considerations: Breakthrough therapy, priority review
Approval date: May 14, 2019

Brinlinta (new indication)
(Ticagrelor; AstraZeneca)
Class/route: P2Y12 platelet inhibitor; oral tablets
New Indication: To reduce the risk for a first myocardial infarction or stroke in high-risk patients with coronary artery disease
Existing Indications: To reduce the risk for cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction
Approval date: June 1, 2020

Cabometyx (new indication)
(Cabozantinib; Exelixis)
Class/route: Tyrosine kinase inhibitor; oral tablets
New Indication: Treatment of hepatocellular carcinoma after sorafenib therapy
Existing Indication: Treatment of renal-cell carcinoma
Approval date: January 14, 2019

Calquence (new indication)
(Acalabrutinib; AstraZeneca)
Class/route: Bruton tyrosine kinase inhibitor; oral capsules
New Indication: Treatment of chronic lymphocytic ­leukemia and small lymphocytic lymphoma
Existing Indication: Treatment of adults with mantle-cell lymphoma after ≥1 therapies
Approval considerations: Breakthrough therapy, priority review, Real-Time Oncology Review
Approval date: November 21, 2019

Cimzia (new indication)
(Certolizumab pegol; UCB)
Class/route: TNF blocker; subcutaneous injection
New Indication: Treatment of adults with active non­radiographic axial spondyloarthritis with objective signs of inflammation
Existing Indications: To reduce the signs and symptoms of moderate-to-severe Crohn’s disease in adults with an inadequate response to conventional therapy; treatment of moderate-to-­severe rheumatoid arthritis in adults; treatment of active psoriatic arthritis in adults; treatment of active ankylosing spondylitis in adults; treatment of moderate-to-­severe plaque psoriasis in adults
Approval date: March 28, 2019

Cyramza (new indications)
(Ramucirumab; Eli Lilly)
Class/route: VEGF receptor 2 antagonist; intravenous injection
New Indications: Treatment of hepatocellular carcinoma in patients with an alpha fetoprotein of ≥400 ng/mL, after sorafenib therapy; first-line treatment, in combination with erlotinib, of metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations
Existing Indications: Treatment of advanced or metasta­tic gastric or gastroesophageal junction adenocarcinoma; treatment, in combination with docetaxel, of metastatic NSCLC progressing during or after chemotherapy; treatment of metastatic colorectal cancer
Approval dates: May 10, 2019 (hepatocellular carci­noma); May 29, 2020 (NSCLC)

Darzalex (new indications)
(Daratumumab; Janssen Biotech)
Class/route: CD38-directed cytolytic antibody; intravenous injection
New Indications: First-line treatment, in combination with lenalidomide and dexamethasone, of multiple myeloma in ASCT-ineligible patients; first-line treatment, in combination with bortezomib, thalidomide, and dexamethasone, of multiple myeloma in ASCT-eligible patients
Existing Indications: First-line treatment, in combination with bortezomib, melphalan, and prednisone, of multiple myeloma in ASCT-ineligible adults; in combination with lenalidomide and dexamethasone, in patients with relapsed or refractory multiple myeloma who have received ≥1 therapies; in combination with bortezomib and dexamethasone, in patients with multiple myeloma who have received ≥1 therapies; as monotherapy in patients who have received ≥3 lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or whose disease is double refractory to a proteasome inhibitor and an immunomodulatory agent
Approval considerations: Real-Time Oncology Review (with lenalidomide and dexamethasone); priority review (with bortezomib, thalidomide, and dexamethasone)
Approval dates: June 27, 2019 (with lenalidomide and dexamethasone); September 26, 2019 (with bortezomib, thalidomide, and dexamethasone)

Darzalex Faspro (new combination)
(Daratumumab and hyaluronidase-fihj; Janssen ­Biotech)
Classes/route: CD38-directed cytolytic antibody and ­endoglycosidase; subcutaneous injection
New combination: Subcutaneous injection of ­daratumumab for multiple myeloma
Indications: First-line treatment, in combination with bortezomib, melphalan, and prednisone, of multiple myeloma, in ASCT-ineligible adults; treatment, in combination with lenalidomide and dexamethasone, in newly diagnosed ASCT-ineligible patients or patients with relapsed or refractory multiple myeloma after ≥1 therapies; treatment, in combination with bortezomib and dexamethasone, of patients with multiple myeloma after ≥1 therapies; treatment of multiple myeloma after ≥3 lines of therapy, including a proteasome inhibitor and an immunomodulatory agent or in patients whose disease is double refractory to a proteasome inhibitor and an immunomodulatory agent
Approval date: May 1, 2020

Descovy (new indication)
(Emtricitabine and tenofovir alafenamide fumarate; Gilead Sciences)
Class/route: HIV nucleoside analog reverse transcriptase inhibitors; oral tablets
New Indication: For pre-exposure prophylaxis to reduce the risk for HIV-1 infection from sexual acquisition in at-risk adults and adolescents weighing ≥35 kg
Existing Indication: Treatment, in combination with other antiretroviral agents, of HIV-1 infection in adults and pediatric patients weighing ≥35 kg; treatment, in combination with other antiretroviral agents other than protease inhibitors that require a cytochrome P3A inhibitor, of HIV-1 infection in pediatric patients weighing ≥25 kg and <35 kg
Limitations of use: Not for use in individuals at risk for HIV-1 from vaginal sex
Approval consideration: Priority review
Approval date: October 3, 2019

Dificid (new indication)
(Fidaxomicin; Merck)
Class/route: Macrolide antibacterial; oral tablets and oral suspension
New Indication: Treatment of Clostridioides difficile–­associated diarrhea in pediatric patients aged ≥6 months
Existing Indication: Treatment of C difficile–associated ­diarrhea in adults
Approval consideration: Priority review
Approval date: January 27, 2020
See also New Formulations listing

Doptelet (new indication)
(Avatrombopag; Dova Pharmaceuticals)
Class/route: Thrombopoietin receptor agonist; oral tablets
New Indication: Treatment of thrombocytopenia in adults with chronic immune thrombocytopenia who have had an insufficient response to a previous therapy
Existing Indication: Treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure
Approval date: June 27, 2019

Dovato (new combination)
(Dolutegravir and lamivudine; ViiV Healthcare)
Classes/route: Integrase strand transfer inhibitor and nucleoside analog reverse transcriptase inhibitor; oral tablets
New combination: First 2-drug fixed-dose complete regimen for the treatment of HIV in treatment-naïve adults
Indication: First-line treatment of HIV-1 infection in adults with no known resistance to dolutegravir and lamivudine
Approval date: April 8, 2019

Dupixent (new indication)
(Dupilumab; Regeneron)
Class/route: IL-4 receptor alpha antagonist; subcutaneous injection
New Indication: Add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyposis in adults
Existing Indications: Treatment of moderate-to-severe atopic dermatitis in adults; as an add-on maintenance treatment of patients aged ≥12 years with moderate-­to-severe asthma and an eosinophilic phenotype or with oral corticosteroid–dependent asthma
Limitations of use: Not for relief of acute bronchospasm or status asthmaticus
Approval consideration: Priority review
Approval date: June 26, 2019
See also New Patient Populations listing

Emgality (new indication)
(Galcanezumab-gnlm; Eli Lilly)
Class/route: Calcitonin gene–related peptide antagonist; subcutaneous injection
New Indication: Treatment of episodic cluster headache
Existing Indication: For prevention of migraine
Approval date: June 4, 2019

Erleada (new indication)
(Apalutamide; Janssen Biotech)
Class/route: Androgen receptor inhibitor; oral tablets
New Indication: Treatment of metastatic castration-­sensitive prostate cancer
Existing Indication: Treatment of nonmetastatic ­castration-resistant prostate cancer
Approval consideration: Priority review
Approval date: September 17, 2019

Eylea (new indication)
(Aflibercept; Regeneron)
Class/route: VEGF inhibitor; intravitreal injection
New Indication: Treatment of diabetic retinopathy
Existing Indications: Treatment of neovascular (wet) age-related macular degeneration; treatment of macular edema after retinal vein occlusion; treatment of diabetic macular edema
Approval date: May 13, 2019

Farxiga (new indications)
(Dapagliflozin; AstraZeneca)
Class/route: Sodium glucose co-transporter 2 inhibitor; oral tablets
New Indications: To reduce the risk for hospitalization for heart failure in adults with type 2 diabetes and established CVD or multiple cardiovascular risk factors; to reduce the risk for cardiovascular death and hospitalizations for heart failure in adults with heart failure (NYHA class II-IV) and reduced ejection fraction, with or without type 2 diabetes
Existing Indication: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Limitations of use: Farxiga is not recommended for patients with type 1 diabetes mellitus or diabetic ketoacidosis
Approval dates: October 21, 2019 (with diabetes);
May 6, 2020 (with or without diabetes)

Fiasp (new indication)
(Insulin aspart injection; Novo Nordisk)
Class/routes: Rapid-acting human insulin analog; sub­cutaneous or intravenous injection
New Indication: Mealtime treatment to improve glycemic control in pediatric patients with diabetes
Existing Indication: To improve glycemic control in adults with diabetes
Approval date: January 6, 2020

Gardasil 9 (new indication)
(HPV 9-valent vaccine, recombinant; Merck)
Class/route: Vaccine; intramuscular injection
New Indication: Prevention, in girls and women aged 9 to 45 years, of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, 58
Existing Indications: Prevention, in girls and women aged 9 to 45 years, of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, 58; prevention of genital warts (condyloma acuminata) resulting from HPV types 6 and 11; prevention of precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58, including grade 2 or 3 cervical intraepithelial neoplasia and cervical adenocarcinoma in situ, grade 1 cervical intraepithelial neoplasia, grade 2 or 3 vulvar intraepithelial neoplasia, grade 2 or 3 vaginal intraepithelial neoplasia, and grades 1-3 anal intraepithelial neoplasia
Limitations of use: Gardasil 9 does not eliminate the necessity of screening for cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers; ­Gardasil 9 has not been demonstrated to protect against disease caused by HPV types not covered by the vaccine and to which a person has been exposed through sexual activity; not all vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers are caused by HPV, and Gardasil 9 protects only against conditions caused by HPV 16, 18, 31, 33, 45, 52, and 58
Approval consideration: Accelerated approval
Approval date: June 12, 2020

Herceptin Hylecta (new combination)
(Trastuzumab and hyaluronidase-oysk; Genentech)
Classes/route: HER2/neu receptor antagonist and ­endoglycosidase; subcutaneous injection
Indication: Treatment of patients with HER2-­overexpressing breast cancer
Approval date: February 28, 2019

Imbruvica (new indications)
(Ibrutinib; AbbVie)
Class/routes: Bruton tyrosine kinase inhibitor; oral ­capsules, oral tablets
New Indications: First-line treatment, in combination with obinutuzumab, of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma; first-line treatment, in combination with rituximab, of patients with chronic lymphocytic leukemia or small lympho­cytic lymphoma
Existing Indications: Treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without deletion 17p; treatment, in combination with bendamustine and rituximab, of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma and deletion 17p; treatment of mantle-cell lymphoma; treatment of marginal-zone lymphoma; treatment of chronic graft-versus-host disease; treatment of Waldenström macroglobulinemia
Approval dates: January 28, 2019 (with obinutuzumab); April 21, 2020 (with rituximab)

Imfinzi (new indication)
(Durvalumab; AstraZeneca)
Class/route: PD-L1 inhibitor; intravenous injection
New Indication: First-line treatment, in combination with etoposide and either carboplatin or cisplatin, of patients with extensive-stage small-cell lung cancer
Existing Indications: Treatment of locally advanced or metastatic urothelial cancer in adults; treatment of ­unresectable stage III NSCLC in adults
Approval considerations: Orphan drug, priority review
Approval date: March 27, 2020

Inlyta (new indications)
(Axitinib; Pfizer)
Class/route: Tyrosine kinase inhibitor; oral tablets
New Indications: First-line treatment, in combination with pembrolizumab, of advanced renal-cell carcinoma; first-line treatment, in combination with avelumab, of advanced renal-cell carcinoma
Existing Indication: Treatment of advanced renal-cell carcinoma after nonresponse to 1 systemic therapy
Approval considerations: Breakthrough therapy (both indications), priority review (both indications)
Approval dates: April 19, 2019 (with pembrolizumab); May 14, 2019 (with avelumab)

Jakafi (new indication)
(Ruxolitinib; Incyte)
Class/route: Janus kinase inhibitor; oral tablets
New Indication: Treatment of steroid-refractory acute graft-versus-host disease in patients aged ≥12 years
Existing Indications: Treatment of intermediate- or high-risk myelofibrosis in adults; treatment of polycythemia vera in adults
Approval consideration: Priority review
Approval date: May 24, 2019

Kadcyla (new indication)
(Ado-trastuzumab emtansine; Genentech)
Classes/route: HER2-targeted antibody and microtubule inhibitor conjugate; intravenous injection
New Indication: Adjuvant treatment of HER2-positive early breast cancer in patients who have residual invasive disease after neoadjuvant treatment with a taxane- and trastuzumab-based regimen
Existing Indications: Treatment of HER2-positive, metastatic breast cancer in patients who have received trastuzumab and a taxane, separately or in combination, or who had disease recurrence during or within 6 months after completing adjuvant therapy
Approval considerations: Breakthrough therapy, priority review, Real-Time Oncology Review
Approval date: May 3, 2019

Keytruda (new indications)
(Pembrolizumab; Merck)
Class/route: PD-1 inhibitor; intravenous injection
New Indications: Adjuvant treatment of melanoma with involvement of lymph node(s) after complete resection; first-line treatment of stage III NSCLC in patients who are not candidates for resection or definitive chemoradiation, or for metastatic NSCLC, and whose tumors express PD-L1, as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; first-line treatment, in combination with axitinib, of advanced renal-cell carcinoma; first-line treatment, as monotherapy in patients whose tumors express PD-L1, or in combination with platinum and fluorouracil, of patients with metastatic or unresectable recurrent head and neck squamous-cell carcinoma; metastatic small-cell lung cancer with disease progression during or after platinum-based chemotherapy and ≥1 other therapies; treatment of recurrent, locally advanced, or metastatic squamous-cell carcinoma of the esophagus in patients whose tumors express PD-L1, as determined by an FDA-approved test, with disease progression after ≥1 lines of systemic therapy; treatment, in combination with lenvatinib, of advanced endometrial carcinoma that is not MSI-H or dMMR and whose disease progressed after systemic therapy and who are ineligible for surgery or radiation; treatment of Bacillus Calmette-Guérin–unresponsive, high-risk, nonmuscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors, in patients who are ineligible for or have elected not to undergo cystectomy
Existing Indications: Treatment of unresectable or metastatic melanoma; treatment, in combination with other drugs, of NSCLC; treatment of small-cell lung cancer; treatment of recurrent or metastatic head and neck squamous-cell carcinoma with disease progression during or after platinum-containing chemotherapy; treatment of classical Hodgkin lymphoma; treatment of primary mediastinal large B-cell lymphoma; treatment of urothelial carcinoma; treatment of MSI-H or dMMR solid tumors; treatment of MSI-H or dMMR colorectal cancer; treatment of gastric cancer; treatment of hepatocellular carcinoma; treatment of Merkel-cell carcinoma; treatment of tumor mutational burden–high cancer; treatment of cutaneous squamous-cell carcinoma
Approval considerations: Accelerated approval (endometrial carcinoma, small-cell lung cancer), breakthrough therapy (endometrial carcinoma, renal-cell carcinoma), orphan drug (melanoma), priority review (bladder cancer, endometrial carcinoma, head and neck cancer, renal-cell carcinoma, carcinoma of the esophagus), Real-Time Oncology Review (endometrial carcinoma)
Approval dates: February 15, 2019 (melanoma); April 11, 2019 (NSCLC); April 19, 2019 (renal-cell carcinoma); June 10, 2019 (head and neck cancer); June 17, 2019 (small-cell lung cancer); July 30, 2019 (carcinoma of the esophagus); September 17, 2019 (endometrial carcinoma); January 8, 2020 (bladder cancer)
See also New Dosage listing

Lenvima (new indication)
(Lenvatinib; Eisai)
Class/route: Multikinase inhibitor; oral capsules
New Indication: Treatment, in combination with pembrolizumab, of advanced endometrial carcinoma that is not MSI-H or dMMR, and in patients whose disease progressed after systemic therapy and who are ineligible for surgery or radiation
Existing Indications: Treatment of locally recurrent or metastatic, progressive, radioactive iodine–refractory differentiated thyroid cancer; treatment, in combination with everolimus, of advanced renal-cell carcinoma after 1 antiangiogenic therapy; first-line treatment of unresectable hepatocellular carcinoma
Approval considerations: Accelerated approval, breakthrough therapy, priority review, Real-Time Oncology Review
Approval date: September 17, 2019

Lonsurf (new indication)
(Trifluridine and tipiracil; Taiho)
Classes/route: A nucleoside metabolic inhibitor and a thymidine phosphorylase inhibitor; oral tablets
New Indication: Treatment of metastatic gastric or gastroesophageal junction adenocarcinoma after ≥2 lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and, if appropriate, HER2/neu-targeted therapy
Existing Indication: Treatment of metastatic colorectal cancer after fluoropyrimidine-, oxaliplatin-, and ­irinotecan-based chemotherapy, an anti-VEGF biologic therapy, and if RAS wild-type, an anti-EGFR therapy
Approval considerations: Orphan drug, priority review
Approval date: February 22, 2019

Lynparza (new indications)
(Olaparib; AstraZeneca)
Class/route: PARP inhibitor; oral tablets
New Indications: Maintenance treatment of deleterious or suspected deleterious germline metastatic pancreatic adenocarcinoma with BRCA mutation, as detected by an FDA-approved test, in adults whose disease has not progressed after ≥16 weeks of a first-line platinum-based chemotherapy regimen; first-line maintenance treatment, in combination with bevacizumab, of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with HRD mutation, defined by a deleterious or suspected deleterious BRCA mutation and/or genomic instability, as detected by an FDA-approved companion diagnostic; treatment of deleterious or suspected deleterious germline or somatic HRR gene mutation–positive metastatic castration-­resistant prostate cancer in adults whose disease progressed after treatment with enzalutamide or abir­aterone, based on an FDA-approved companion diagnostic test
Existing Indications: Treatment of ovarian cancer; treatment of deleterious or suspected deleterious germline BRCA-positive, HER2-negative metastatic breast cancer in adults
Approval considerations: Breakthrough therapy (prostate cancer); priority review (pancreatic cancer, prostate cancer)
Approval dates: December 27, 2019 (pancreatic cancer); May 8, 2020 (ovarian cancer, with bevacizumab); May 20, 2020 (prostate cancer)

Mycamine (new indications)
(Micafungin for injection; Astellas Pharma)
Class/route: Echinocandin; intravenous injection
New Indications: Treatment of candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses without meningoencephalitis and/or ocular dissemination, in patients aged <4 months
Existing Indications: Treatment of candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses without meningoencephalitis and/or ocular dissemination in patients aged ≥4 months; treatment of esophageal candidiasis in patients aged ≥4 months; prophylaxis of Candida infections in patients aged ≥4 months undergoing hematopoietic stem-cell transplantation
Limitations of use: The safety and effectiveness of micafungin have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in patients aged <4 months because a higher dose may be needed; micafungin has not been adequately studied in patients with endocarditis, osteomyelitis, or meningoencephalitis resulting from Candida; the efficacy of micafungin against infections caused by fungi other than Candida has not been established
Approval date: January 8, 2020

Nerlynx (new indication)
(Neratinib; Puma Biotechnology)
Class/route: Tyrosine kinase inhibitor; oral tablets
New Indication: Treatment, in combination with capecitabine, of advanced or metastatic HER2-positive breast cancer in adults, after ≥2 anti-HER2–based regimens in the metastatic setting
Existing Indication: Extended adjuvant treatment of early-­stage HER2-positive breast cancer in adults, to follow adjuvant trastuzumab-based therapy
Approval consideration: Fast track
Approval date: February 26, 2020

Ofev (new indications)
(Nintedanib; Boehringer Ingelheim)
Class/route: Tyrosine kinase inhibitor; oral capsules
New Indications: To slow the rate of pulmonary function decline in patients with systemic sclerosis–associated interstitial lung disease; treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype
Existing Indication: Treatment of idiopathic pulmonary fibrosis
Approval considerations: Orphan drug (systemic sclerosis), priority review (interstitial lung disease with ­systemic sclerosis)
Approval dates: September 6, 2019 (systemic sclerosis); March 9, 2020 (fibrosing interstitial lung disease)

Opdivo (new indication)
(Nivolumab; Bristol Myers Squibb)
Class/route: PD-1 inhibitor; intravenous injection
New Indication: Treatment of unresectable advanced, recurrent or metastatic esophageal squamous-cell carcinoma after fluoropyrimidine-based and platinum-based chemotherapy
Existing Indications: Treatment of unresectable or metastatic melanoma; treatment of metastatic NSCLC; treatment of metastatic renal-cell carcinoma; treatment of Hodgkin lymphoma; treatment of recurrent or metastatic squamous-cell carcinoma of the head and neck; treatment of locally advanced or metastatic urothelial carcinoma; treatment of MSI-H or dMMR metastatic colorectal cancer; treatment of hepatocellular carcinoma after sorafenib therapy; adjuvant treatment of melanoma with involvement of lymph nodes or metastatic disease in patients who have had complete resection; treatment of metastatic small-cell lung cancer in patients whose disease progressed after platinum-based chemotherapy and ≥1 other lines of therapy
Approval consideration: Accelerated approval
Approval date: June 10, 2020

Opdivo plus Yervoy (new indications)
(Nivolumab plus ipilimumab; Bristol Myers Squibb)
Classes/route: PD-1 inhibitor and CTLA-4 inhibitor; ­intravenous injection
New Indications: Treatment of hepatocellular carcinoma after sorafenib therapy; first-line treatment of metastatic NSCLC expressing PD-L1 (≥1%), as determined by an FDA-approved test, and no EGFR or ALK genomic tumor aberrations; first-line treatment, in combination with 2 cycles of platinum-doublet chemotherapy, of metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations
Existing Indications: Treatment of BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or ­metastatic melanoma; first-line treatment of intermediate- or poor-risk advanced renal-cell carcinoma; treatment of MSI-H or dMMR metastatic colorectal cancer that progressed after chemotherapy in patients aged ≥12 years
Approval considerations: Accelerated approval (hepatocellular carcinoma); breakthrough therapy (hepatocellular carcinoma), fast track (with chemotherapy for NSCLC), priority review (hepatocellular carcinoma, NSCLC, with chemotherapy for NSCLC), Real-Time Oncology Review (with chemotherapy for NSCLC)
Approval dates: March 10, 2020 (hepatocellular carcinoma); May 15, 2020 (NSCLC); May 26, 2020 (with chemotherapy for NSCLC)

Otezla (new indication)
(Apremilast; Amgen)
Class/route: Phosphodiesterase 4 inhibitor; oral tablets
New Indication: Treatment of oral ulcers associated with Behçet’s disease in adults
Existing Indications: Treatment of active psoriatic arthritis in adults; treatment of moderate-to-severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy
Approval date: July 19, 2019

Ozempic (new indication)
(Semaglutide; Novo Nordisk)
Class/route: Glucagon-like peptide 1 receptor agonist; subcutaneous injection
New Indication: To reduce the risk for major adverse cardiovascular events in adults with type 2 diabetes and established CVD
Existing Indications: As an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes
Limitations of use: Semaglutide has not been studied in patients with a history of pancreatitis, so consider another therapy; not indicated for type 1 diabetes or for diabetic ketoacidosis
Approval date: January 16, 2020

Pomalyst (new indication)
(Pomalidomide; Bristol Myers Squibb)
Class/route: Thalidomide analog; oral tablets
New Indication: Treatment of patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy, or in patients with Kaposi sarcoma who are HIV-negative
Existing Indication: Treatment, in combination with dexamethasone, of patients with multiple myeloma who have received ≥2 therapies, including lenalidomide and a proteasome inhibitor, and whose disease progressed during or within 60 days of completion of the last therapy
Approval considerations: Accelerated approval, breakthrough therapy, orphan drug
Approval date: May 15, 2020

Reblozyl (new indication)
(Luspatercept-aamt; Celgene)
Class/route: Erythroid maturation agent; subcutaneous injection
New Indication: Treatment of anemia that did not ­respond to treatment with an erythropoiesis-stimulating agent and required ≥2 red blood cell units over 8 weeks in adults with very low- to intermediate-risk myelo­dysplastic syndromes with ring sideroblasts or with
myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis
Existing Indication: Treatment of anemia in adults with beta-thalassemia who require regular red blood cell transfusions
Limitations of use: Not indicated as a substitute for red blood cell transfusions in patients who require immediate correction of anemia
Approval considerations: Fast track, orphan drug
Approval date: April 3, 2020
See also New Molecular Entities and New Biologic ­License Applications listing

Recarbrio (new combination/new indication)
(Imipenem, cilastatin, and relebactam; Merck)
Classes/route: Penem antibacterial, renal dehydro­peptidase inhibitor, and beta-lactamase inhibitor; ­intravenous injection
New combination: Intravenous injection for the treatment of bacterial infections
New Indication: Treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in patients aged ≥18 years
Initial Indication: Treatment of complicated urinary tract infections, including pyelonephritis, and complicated intra-abdominal infections caused by susceptible Gram-negative bacteria in patients aged ≥18 years with limited or no alternative treatment options
Approval considerations: Fast track (new indication), priority review (new combination, new indication), Qualified Infectious Disease Product (new combination, new indication)
Approval dates: July 16, 2019 (new combination); June 5, 2020 (new indication)
See also New Molecular Entities and New Biologic ­License Applications listing

Revlimid (new indications)
(Lenalidomide; Celgene)
Class/route: Thalidomide analog; oral capsules
New Indications: Treatment, in combination with rituximab, of previously treated follicular lymphoma and of marginal-zone lymphoma
Existing Indications: Treatment, in combination with dexamethasone, of multiple myeloma; for maintenance treatment of multiple myeloma after ASCT; treatment of transfusion-dependent anemia resulting from low- or intermediate-1–risk myelodysplastic syndromes associated with a deletion 5q, with or without additional cytogenetic abnormalities; treatment of mantle-cell lymphoma in patients whose disease relapsed or progressed after 2 therapies, 1 of which was bortezomib
Limitations of use: Not recommended for patients with chronic lymphocytic leukemia outside of clinical trials
Approval considerations: Orphan drug, priority review
Approval date: May 28, 2019

Rubraca (new indication)
(Rucaparib; Clovis Oncology)
Class/route: PARP inhibitor; oral tablets
New Indication: Treatment of adults with a deleterious BRCA mutation, germline and/or somatic-associated, metastatic castration-resistant prostate cancer after androgen receptor–directed therapy and a taxane-based chemotherapy
Existing Indications: Treatment of women with advanced ovarian cancer who have received ≥2 chemotherapies and whose tumors have a deleterious BRCA gene mutation, as identified by an FDA-approved test; maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy
Approval consideration: Accelerated approval
Approval date: May 15, 2020

Soliris (new indication)
(Eculizumab; Alexion)
Class/route: Complement inhibitor; intravenous injection
New Indication: Treatment of neuromyelitis optica spectrum disorder in adults with anti–aquaporin-4 antibody
Existing Indications: Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis; treatment of atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy; treatment of adults with generalized myasthenia gravis with anti–acetylcholine receptor antibody
Limitation of use: Not indicated for treatment of Shiga toxin Escherichia coli–related hemolytic uremic syndrome
Approval considerations: Priority review, REMS
Approval date: June 27, 2019

Taltz (new indication)
(Ixekizumab; Eli Lilly)
Class/route: Humanized IL-17A antagonist; subcutaneous injection
New Indication: Treatment of active nonradiographic axial spondyloarthritis with objective signs of inflammation
Existing Indications: Treatment of patients aged ≥6 years with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; treatment of active psoriatic arthritis in adults; treatment of active ankylosing spondylitis in adults
Approval date: June 1, 2020
See also New Patient Population listing

Tecentriq (new indications)
(Atezolizumab; Genentech)
Class/route: PD-L1 inhibitor; intravenous infusion
New Indications: Treatment, in combination with paclitaxel protein-bound, of unresectable locally advanced or metastatic triple-negative breast cancer in adults whose tumors express PD-L1, as determined by an FDA-approved test; first-line treatment, in combination with carboplatin and etoposide, of extensive-stage small-cell lung cancer in adults; first-line treatment of metastatic NSCLC in adults whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations; first-line treatment, in combination with paclitaxel protein-bound and carboplatin, of metastatic nonsquamous NSCLC in adults with no EGFR or ALK genomic tumor aberrations; treatment, in combination with bevacizumab, of unresectable or metastatic hepatocellular carcinoma after systemic therapy
Existing Indications: As monotherapy or in combination with other agents, for treatment of several types, each, of NSCLC, small-cell lung cancer, urothelial cancer, and triple-negative breast cancer
Approval considerations: Accelerated approval (triple-negative breast cancer), breakthrough therapy (hepatocellular carcinoma), priority review (hepatocellular carcinoma, triple-negative breast cancer, nonsquamous NSCLC with high PD-L1 expression, small-cell lung cancer,); ­Real-Time Oncology Review (hepatocellular carcinoma)
Approval dates: March 8, 2019 (triple-negative breast cancer); March 18, 2019 (small-cell lung cancer); December 3, 2019 (NSCLC without EGFR or ALK); May 18, 2020 (NSCLC with high PD-L1 expression); May 29, 2020 (hepatocellular carcinoma)

Tibsovo (new indication)
(Ivosidenib; Agios)
Class/route: IDH1 inhibitor; oral tablets
New Indication: Treatment of newly diagnosed acute myeloid leukemia in patients aged ≥75 years with a ­susceptible IDH1 mutation, as detected by an FDA-­approved test, or patients whose comorbidities preclude intensive induction chemotherapy
Existing Indication: Treatment of relapsed or refractory acute myeloid leukemia in adults aged ≥75 years with a susceptible IDH1 mutation or who have comorbidities that preclude intensive induction chemotherapy
Approval considerations: Orphan drug, priority review, Real-Time Oncology Review
Approval date: May 2, 2019

Tivicay (new indication)
(Dolutegravir; ViiV Healthcare)
Class/routes: HIV-1 integrase strand transfer inhibitor; oral tablets
New Indication: Treatment, in combination with other antiretroviral agents, of HIV-1 infection in pediatric patients weighing ≥3 kg
Existing Indications: First-line or later treatment, in combination with other antiretroviral agents, of HIV-1 infection in adults, and in pediatric patients aged ≥4 weeks and weigh ≥40 kg who are integrase strand transfer inhibitor–naïve; treatment, in combination with rilpivirine, as a complete regimen of HIV-1 infection in adults, to replace the current antiretroviral regimen in those who are virologically suppressed with a stable antiretroviral regimen for ≥6 months and have no history of treatment nonresponse or resistance
Approval date: June 12, 2020
Approval consideration: Priority review
See also New Formulations listing

Trikafta (new combination)
(Elexacaftor, tezacaftor, and ivacaftor; Vertex)
Class/route: 2 CFTR correctors and CFTR potentiator; oral tablets
Indication: Treatment of cystic fibrosis in patients aged ≥12 years who have ≥1 F508del mutations in the CFTR gene
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: October 21, 2019
See also New Molecular Entities and New Biologic ­License Applications listing

Ultomiris (new indication)
(Ravulizumab-cwvz; Alexion)
Class/route: Complement inhibitor; intravenous injection
New Indication: Treatment of atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy in patients aged ≥1 months
Existing Indication: Treatment of paroxysmal nocturnal hemoglobinuria in adults
Limitations of use: Not indicated for Shiga toxin E coli–related hemolytic uremic syndrome
Approval consideration: REMS
Approval date: October 18, 2019

Vascepa (new indication)
(Icosapent ethyl; Amarin)
Class/route: Ethyl ester of eicosapentaenoic acid; oral capsules
New Indication: An adjunct to maximally tolerated statin therapy, to reduce the risks for myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adults with elevated (≥150 mg/dL) triglyceride levels and established CVD or diabetes and ≥2 additional risk factors for CVD
Existing Indication: As an adjunct to diet, to reduce triglyceride levels in adults with severe (≥500 mg/dL) ­hypertriglyceridemia
Limitations of use: The effect of icosapent ethyl on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined
Approval date: December 13, 2019

Venclexta (new indication)
(Venetoclax; AbbVie/Genentech)
Class/route: BCL-2 inhibitor; oral tablets
New Indication: Treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma in adults
Existing Indication: First-line treatment, in combination with azacitidine, decitabine, or low-dose cytarabine, of acute myeloid leukemia in adults aged ≥75 years, or those who have comorbidities that preclude intensive induction chemotherapy
Approval considerations: Breakthrough therapy, orphan drug, priority review, Real-Time Oncology Review
Approval date: May 15, 2019

Xtandi (new indication)
(Enzalutamide; Astellas Pharma)
Class/route: Androgen receptor inhibitor; oral capsules
New Indication: Treatment of metastatic castration-sensitive prostate cancer
Existing Indication: Treatment of castration-resistant prostate cancer
Approval consideration: Priority review
Approval date: December 16, 2019

Zejula (new indications)
(Niraparib; GlaxoSmithKline)
Class/route: PARP inhibitor; oral capsules
New Indications: Treatment of recurrent ovarian cancer and HRD-positive status after ≥3 chemotherapy regimens; maintenance treatment of all women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have had a complete or partial response to first-line platinum-based chemotherapy, regardless of HRD status, such as a BRCA mutation
Existing Indication: Treatment of recurrent ovarian cancer in women who have had a response to platinum-­based chemotherapy
Approval considerations: Priority review (2019, 2020), Real-Time Oncology Review (2020)
Approval dates: October 23, 2019 (recurrent ovarian cancer); April 29, 2020 (advanced ovarian cancer)

 

ALK indicates anaplastic lymphoma kinase; ASCT, autologous stem-cell transplant; BCL-2, B-cell leukemia/lymphoma 2; CFTR, cystic fibrosis transmembrane conductance regulator; CTLA, cytotoxic T-lymphocyte–associated protein 4; CVD, cardiovascular disease; dMMR, mismatch repair-deficient; EGFR, epidermal growth factor receptor; FDA, US Food and Drug Administration; HCV, hepatitis C virus; HER2, human epidermal growth factor receptor 2; HIV, human immunodeficiency virus type 1; HPV, human papillomavirus; HRD, homologous recombination deficiency; HRR, homologous recombination repair; IDH1, isocitrate dehydrogenase-1; IL, interleukin; MSI-H, microsatellite instability-high; NSCLC, non–small-cell lung cancer; PARP, poly (ADP-ribose) polymerase; PD-1, programmed cell-death receptor 1; PD-L1, programmed cell-death ligand 1; REMS, Risk Evaluation and Mitigation Strategy; RNA, ribonucleic acid; TNF, tumor necrosis factor; VEGF, vascular endothelial growth factor.


IV. New Dosages, Dosage Strengths, Formulations, and New Patient Populations

Ajovy (new formulation)
(Fremanezumab-vfrm; Teva)
Class/route: Calcitonin gene-related peptide antagonist; subcutaneous injection
New formulation: Single-dose prefilled autoinjector
Existing formulation: Single-dose prefilled syringe
Indication: Preventive treatment of migraine in adults
Approval date: January 28, 2020

Avaclyr (new formulation)
(Acyclovir; Fera Pharmaceuticals)
Class/route: Herpes simplex virus nucleoside analog DNA polymerase inhibitor; 3% topical ophthalmic ointment
New formulation: Ophthalmic antiviral ointment
Existing formulation: Acyclovir intravenous injection [different trade name]
Indication: Treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex virus 1 or 2 infection
Approval consideration: Orphan drug
Approval date: April 1, 2019

Baqsimi (new formulation)
(Glucagon; Eli Lilly)
Class/route: Nasal glucagon; intranasal powder
New formulation: Intranasal powder administration as emergency treatment of severe hypoglycemia
Existing formulation: Injectable glucagon (different trade name)
Indication: Treatment of severe hypoglycemia in patients aged ≥4 years with diabetes
Approval date: July 24, 2019

Benlysta (new patient population)
(Belimumab; GlaxoSmithKline)
Class/routes: B-lymphocyte stimulator–specific inhibitor; intravenous and subcutaneous injection
New patient population: Pediatric patients aged ≥5 years with systemic lupus erythematosus
Existing patient population: Adults with systemic lupus erythematosus
Indication: Treatment of active autoantibody-positive systemic lupus erythematosus in patients aged ≥5 years who are receiving standard therapy
Limitations of use: The efficacy of belimumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus; belimumab has not been studied in combination with other biologics or intravenous cyclophosphamide
Approval consideration: Priority review
Approval date: April 26, 2019

Corlanor (new formulation)
(Ivabradine; Amgen)
Class/routes: Hyperpolarization-activated cyclic nucleotide-­gated channel blocker; oral tablets and oral ­solution
New formulation: Oral solution
Existing formulation: Oral tablets
Indications: To reduce hospitalization risk for worsening HF in adults with stable, symptomatic chronic HF with reduced left-ventricular ejection fraction; treatment of stable symptomatic HF that results from dilated cardiomyopathy in pediatric patients aged ≥6 months
Approval date: April 22, 2019

Darzalex (new dosage)
(Daratumumab; Janssen Biotech)
Class/route: CD38-directed cytolytic antibody; intravenous injection
New dosage: Split dosing of initial dose infused over 2 consecutive days
Existing dosage: Initial dose infused as a single dose
Indications: First-line treatment, in combination with bortezomib, melphalan, and prednisone, of multiple myeloma in ASCT-ineligible adults; first-line treatment, in combination with bortezomib, thalidomide, and dexamethasone, of ASCT-eligible patients with multiple myeloma; treatment, in combination with lenalidomide and dexamethasone, of ASCT-ineligible patients with multiple myeloma or with relapsed or refractory multiple myeloma, after ≥1 therapies; treatment of multiple myeloma, in combination with pomalidomide and dexamethasone, after ≥2 therapies, including lenalidomide and a proteasome inhibitor; treatment, in combination with bortezomib and dexamethasone, of multiple myeloma, after ≥1 previous therapies; treatment of multiple myeloma, after ≥3 lines of therapy, including a proteasome inhibitor and an immunomodulatory agent or in patients whose disease is double refractory to a proteasome inhibitor and an immunomodulatory agent
Approval date: February 12, 2019
See also New Indications and New Combinations listing

Dificid (new formulation)
(Fidaxomicin; Merck)
Class/routes: Macrolide antibacterial; oral tablets and oral suspension
New formulation: Oral suspension
Existing formulation: Oral tablets
Indication: Treatment of Clostridioides difficile–associated diarrhea in adults and pediatric patients aged ≥6 months
Approval consideration: Priority review
Approval date: January 27, 2020
See also New Indications and New Combinations listing

Dupixent (new patient populations)
(Dupilumab; Regeneron)
Class/route: IL-4 receptor alpha antagonist; subcutaneous injection
New patient populations: Adolescents aged 12 to 17 years with moderate-to-severe atopic dermatitis that is not adequately controlled with topical prescription therapies, or when those therapies are not advisable; treatment of children aged 6 to 11 years with moderate-­to-severe atopic dermatitis that is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Existing patient population: Adults with moderate-to-­severe atopic dermatitis
Indications: Treatment, with or without topical corticosteroids, of moderate-to-severe atopic dermatitis in patients aged ≥6 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable; as an add-on maintenance treatment of moderate-to-severe asthma in patients aged ≥12 years with an eosinophilic phenotype or with oral corticosteroid–dependent asthma; as an add-on maintenance treatment for inadequately controlled chronic rhinosinusitis with nasal polyposis in adults
Limitations of use: Not for relief of acute bronchospasm or status asthmaticus
Approval considerations: Breakthrough therapy, priority review
Approval dates: March 11, 2019 (ages 12-17 years) and May 26, 2020 (ages 6-11 years)
See also New Indications and New Combinations listing

Entresto (new patient population)
(Sacubitril and valsartan; Novartis)
Classes/route: Neprilysin inhibitor and angiotensin II receptor blocker; oral tablets
New patient population: Patients aged ≥1 years with symptomatic HF and systemic left-ventricular systolic dysfunction
Existing patient population: Adults with symptomatic HF with systemic left-ventricular systolic dysfunction
Indications: To reduce the risk for cardiovascular death and hospitalization for HF in patients with chronic HF (NYHA class II-IV) and reduced ejection fraction; treatment of symptomatic HF with systemic left-­ventricular systolic dysfunction in pediatric patients aged ≥1 years
Approval date: October 1, 2020

Epclusa (new patient population)
(Sofosbuvir and velpatasvir; Gilead Sciences)
Classes/route: HCV nucleotide analog NS5B polymerase inhibitor and HCV NS5A inhibitor; oral tablets
New patient population: Pediatric patients aged ≥6 years or weighing ≥17 kg
Existing patient population: Adult patients
Indication: Treatment, in combination with ribavirin, of adults and pediatric patients aged ≥6 years or weighing ≥17 kg, with chronic HCV genotypes 1-6 without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis
Approval date: March 19, 2020

Eucrisa (new patient population)
(Crisaborole; Pfizer)
Class/route: PDE-4 inhibitor; topical ointment
New patient population: Pediatric patients aged ≥3 months
Existing patient population: Adults and pediatric patients aged ≥2 years
Indication: Topical treatment of mild-to-moderate atopic dermatitis in adults and pediatric patients aged ≥3 months
Approval date: March 24, 2020

Eylea (new formulation)
(Aflibercept; Regeneron)
Class/route: VEGF inhibitor; intravitreal injection
New formulation: 2-mg, single-dose, sterilized prefilled syringe
Existing formulation: 2-mg/0.05-mL solution in a single-­dose vial
Indications: Treatment of neovascular (wet) age-related macular degeneration; treatment of macular edema after retinal vein occlusion; treatment of diabetic macular edema; treatment of diabetic retinopathy
Approval date: August 13, 2019

Ferriprox (new dosage)
(Deferiprone; Chiesi Global Rare Diseases)
Class/route: Iron chelator; oral tablets
New dosage: Twice-daily 100-mg tablets, which eliminates the mid-day dose
Previous dosage: Mid-day dose is no longer available
Indication: Treatment of patients with transfusional iron overload from thalassemia syndromes, when current chelation therapy is inadequate
Limitations of use: The safety and efficacy of deferiprone have not been established for the treatment of transfusional iron overload in patients with other chronic anemias
Approval date: May 21, 2020

Fragmin (new patient population)
(Dalteparin sodium; Pfizer)
Class/route: Low-molecular-weight heparin; subcutaneous injection
New patient population: Pediatric patients aged ≥1 months to prevent recurrence of symptomatic VTE
Existing patient population: Adults with VTE
Indications: Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction; prophylaxis of deep-vein thrombosis in abdominal surgery, hip replacement surgery, or medical patients with severely restricted mobility during acute illness; extended treatment of symptomatic VTE to reduce ­recurrence in adults with cancer; treatment of symptomatic VTE to ­reduce recurrence in patients aged ≥1 months
Limitations of use: Not indicated for acute VTE
Approval consideration: Priority review
Approval date: May 16, 2019

Harvoni (new dosage strength/new formulation/new patient population)
(Ledipasvir and sofosbuvir; Gilead)
Classes/routes: HCV NS5A inhibitor and HCV nucleotide analog NS5B polymerase inhibitor; oral tablets and oral pellets
New dosage strength: 45-mg/200-mg tablets
Existing dosage strength: 90-mg/400-mg tablets
New formulation: Oral pellets
Existing formulation: Oral tablets
New patient population: Patients aged ≥3 years
Existing patient populations: Adults and pediatric patients aged ≥12 years or weighing ≥35 kg with HCV infection
Indications: Treatment of chronic HCV in patients aged ≥3 years with genotype 1, 4, 5, or 6 infection and no cirrhosis or with compensated cirrhosis; treatment, in combination with ribavirin, of genotype 1 infection with decompensated cirrhosis; treatment, in combination with ribavirin, of genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis in patients who are liver transplant recipients
Approval considerations: Orphan drug, priority review
Approval date: August 28, 2019

Hemady (new dosage strength)
(Dexamethasone; Dexcel Pharma)
Class/route: Corticosteroid; oral tablets
New dosage strength: 20-mg tablets
Existing dosage strengths: 0.5-mg, 0.75-mg, 1-mg, 1.5-mg, 2-mg, 4-mg, and 6-mg tablets
Indication: Treatment, in combination with other ­antimyeloma drugs, of multiple myeloma in adults
Approval consideration: Orphan drug
Approval date: October 3, 2019

Jatenzo (new formulation)
(Testosterone undecanoate; Clarus Therapeutics)
Class/route: Androgen; intramuscular injection and oral capsules
New formulation: Oral capsules
Existing formulation: Intramuscular injection
Indication: Testosterone replacement therapy in men with a deficiency or absence of endogenous testosterone
Limitations of use: The safety and efficacy of testosterone undecanoate in males aged <18 years have not been ­established
Approval date: March 27, 2019

Jublia (new patient population)
(Efinaconazole; Bausch Health/Ortho Dermatologics)
Class/route: Azole antifungal; topical solution
New patient population: Pediatric patients aged ≥6 years with onychomycosis
Existing patient population: Adults with onychomycosis
Indication: Topical treatment of onychomycosis of the toenail(s) that results from Trichophyton rubrum and Trichophyton mentagrophytes
Approval date: April 29, 2020

Keytruda (new dosage)
(Pembrolizumab; Merck)
Class/route: PD-1 inhibitor; intravenous injection
New dosage: 400 mg every 6 weeks
Existing dosage: 200 mg every 3 weeks
Indications: Treatment of melanoma; non–small-cell lung cancer; small-cell lung cancer; head and neck squamous-cell cancer; classical Hodgkin lymphoma; primary mediastinal large B-cell lymphoma; urothelial carcinoma; MSI-H or dMMR solid tumors progressing after previous therapies; gastric cancer; esophageal cancer; cervical cancer; hepatocellular carcinoma; Merkel-cell carcinoma; renal-cell carcinoma; endometrial carcinoma that is not MSI-H or dMMR
Approval consideration: Accelerated approval
Approval date: April 28, 2020
See also New Indications and New Combinations

Mavenclad (new formulation)
(Cladribine; EMD Serono)
Class/route: Purine antimetabolite; intravenous infusion and oral tablets
New formulation: Oral tablets
Existing formulation: Intravenous infusion
Indication: Treatment of relapsing forms of multiple sclerosis, including relapsing-remitting disease and active secondary progressive disease, in adults
Limitations of use: Not recommended for patients with clinically isolated syndrome
Approval date: March 29, 2019

Mavyret (new dosage/new patient population)
(Glecaprevir and pibrentasvir; AbbVie)
Class/route: Fixed-dose combination of HCV NS3/4A protease inhibitor and HCV NS5A inhibitor; oral ­tablets
New dosage: First-line treatment for 8 weeks of adults and certain pediatric patients with HCV genotypes 1-6 without cirrhosis or with compensated cirrhosis
Existing dosage: Treatment for ≥12 weeks of patients with compensated cirrhosis
New patient population: Newly diagnosed patients aged ≥12 years or weighing ≥99 lb with HCV genotype 1-6 and compensated cirrhosis
Existing patient population: Adults with chronic HCV genotype 1-6 without cirrhosis or with mild cirrhosis
Indications: Treatment of patients aged ≥12 years or weighing ≥45 kg with chronic HCV genotype 1-6 infection without cirrhosis or with compensated cirrhosis; treatment of HCV genotype 1 infection in patients aged ≥12 years or weighing ≥45 kg who have received a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both
Approval date: September 26, 2019

Procysbi (new formulation)
(Cysteamine bitartrate; Horizon Therapeutics)
Class/routes: Cystine-depleting agent; delayed-release oral capsules and oral granules
New formulation: Delayed-release oral granules
Existing formulation: Delayed-release oral capsules
Indication: Treatment of nephropathic cystinosis in adults and pediatric patients aged ≥1 years
Approval date: February 18, 2020

Rituxan (new patient population)
(Rituximab; Genentech)
Class/route: CD20-directed cytolytic antibody; intravenous injection
New patient population: Pediatric patients aged ≥2 years with granulomatosis with polyangiitis (Wegener’s granulomatosis) or with microscopic polyangiitis
Existing patient population: Adults with granulomatosis with polyangiitis or with microscopic polyangiitis
Indications: Treatment of non-Hodgkin lymphoma in adults; treatment of chronic lymphocytic leukemia in adults; treatment, in combination with methotrexate, of moderate-to-severe rheumatoid arthritis in adults with an inadequate response to ≥1 TNF antagonist therapies; treatment, in combination with glucocorticoids, of granulomatosis with polyangiitis or with microscopic polyangiitis in adults; treatment, in combination with glucocorticoids, of granulomatosis with polyangiitis or with microscopic polyangiitis in patients aged ≥2 years; treatment of moderate-to-severe pemphigus vulgaris in adults
Approval consideration: Priority review
Approval date: September 27, 2019

Ruzurgi (new patient population)
(Amifampridine; Jacobus Pharmaceutical)
Class/route: Potassium channel blocker; oral tablets
New patient population: Patients aged 6 to <17 years with Lambert-Eaton myasthenic syndrome
Existing patient population: Adults with Lambert-Eaton myasthenic syndrome
Indications: Treatment of Lambert-Eaton myasthenic syndrome in adults; treatment of Lambert-Eaton myasthenic syndrome in patients aged 6 years to <17 years
Approval considerations: Fast track, orphan drug, priority review
Approval date: May 6, 2019

Rybelsus (new formulation)
(Semaglutide; Novo Nordisk)
Class/route: GLP-1 receptor agonist; oral tablets
New formulation: Oral tablets [injectable formulation has a different trade name]
Indication: As an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus
Limitations of use: Not recommended as first-line therapy for patients inadequately controlled with diet and exercise; has not been studied in patients with a history of pancreatitis; not indicated for patients with type 1 diabetes or treatment of diabetic ketoacidosis
Approval date: September 20, 2019

Sovaldi (new formulation/new patient population)
(Sofosbuvir; Gilead)
Class/route: HCV nucleotide analog NS5B polymerase inhibitor; oral tablets and pellets
New formulation: Oral pellets
Existing formulation: Oral tablets
New patient population: Patients aged ≥3 years with HCV
Existing patient populations: Adults and pediatric patients aged ≥12 years with HCV
Indications: Treatment, as part of a combination anti­viral treatment regimen, of genotype 1-4 chronic HCV infection without cirrhosis or with compensated cirrhosis in patients aged ≥12 years; treatment, in combination with ribavirin, of genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in pediatric patients aged ≥3 years
Approval date: August 28, 2019

Symdeko (new dosage strength/new patient population)
(Tezacaftor plus ivacaftor, ivacaftor; Vertex)
Class/route: CFTR corrector and CFTR potentiator; oral tablets
New dosage strength: Tezacaftor 50-mg/ivacaftor 75-mg fixed-dose combination tablets and ivacaftor 75-mg tablets
Existing dosage strength: Tezacaftor 100-mg plus ivacaftor 150-mg fixed-dose combination tablets and ivacaftor 150-mg tablets
New patient population: Patients aged 6 to 11 years with cystic fibrosis and CFTR gene mutations
Existing patient population: Patients aged ≥12 years with cystic fibrosis and CFTR gene mutations
Indication: Treatment of cystic fibrosis in patients aged ≥6 years who are homozygous for the F508del mutation or who have ≥1 mutations in the CFTR gene that is responsive to tezacaftor plus ivacaftor
Approval consideration: Priority review
Approval date: June 21, 2019

Taltz (new patient population)
(Ixekizumab; Eli Lilly)
Class/route: Humanized IL-17A antagonist; subcutaneous injection
New patient population: Pediatric patients aged 6-18 years with moderate-to-severe plaque psoriasis
Existing patient population: Adults with moderate-to-­severe plaque psoriasis
Indications: Treatment of patients aged ≥6 years with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; treatment of active psoriatic arthritis in adults; treatment of active ankylosing spondylitis in adults; treatment of active nonradiographic axial spondyloarthritis with objective signs of inflammation
Approval date: March 30, 2020
See also New Indications listing

Tivicay PD (new formulation)
(Dolutegravir; ViiV Healthcare)
Class/routes: HIV type 1 integrase strand transfer inhibitor; tablets for oral suspension
New formulation: Tablets for oral suspension
Existing formulation: Oral tablets
Indication: Treatment, in combination with other anti­retroviral agents, of HIV-1 infection in treatment-­naïve or previously treated adults, and in treatment-­naïve or previously treated pediatric patients who are integrase strand transfer inhibitor–naïve, aged ≥4 weeks and weigh ≥3 kg
Approval consideration: Priority review
Approval date: June 12, 2020
See also New Indications listing

Tremfya (new formulation)
(Guselkumab; Janssen)
Class/route: IL-23 blocker; subcutaneous injection
New formulation: Single-dose One-Press patient-­controlled injector
Existing formulation: Single-dose prefilled syringe
Indication: Treatment of patients with moderate-to-­severe plaque psoriasis who are candidates for systemic therapy or phototherapy
Approval date: February 27, 2019

Triferic AVNU (new formulation)
(Ferric pyrophosphate citrate; Rockwell Medical)
Class/route: Iron replacement; intravenous infusion
New formulation: Direct intravenous infusion
Existing formulation: Solution or powder added to bi­carbonate concentrate for use in hemodialysis
Indication: Replacement of iron to maintain hemoglobin in adults with hemodialysis-dependent chronic kidney disease
Limitations of use: Not intended for patients receiving peritoneal dialysis; has not been studied with home hemodialysis
Approval date: March 27, 2019

Victoza (new patient population)
(Liraglutide; Novo Nordisk)
Class/route: GLP-1 receptor agonist; subcutaneous ­injection
New patient population: Pediatric patients aged ≥10 years with type 2 diabetes
Existing patient population: Adults with type 2 diabetes
Indications: To improve glycemic control in patients aged ≥10 years with type 2 diabetes, as an adjunct to diet and exercise; to reduce the risk for major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease
Limitations of use: Not for treatment of type 1 diabetes or diabetic ketoacidosis; has not been studied in combination with prandial insulin
Approval consideration: Priority review
Approval date: June 17, 2019

 

ASCT indicates autologous stem-cell transplant; CFTR, cystic fibrosis transmembrane conductance regulator; dMMR, mismatch repair-deficiency; FDA, US Food and Drug Administration; GLP, glucagon-like peptide; HCV, hepatitis C virus; HER2, human epidermal growth factor receptor 2; HF, heart failure; IL, interleukin; MSI-H, microsatellite instability-high; NYHA, New York Heart Association; PD-1, programmed cell-death receptor 1; PDE, phosphodiesterase; REMS, Risk Evaluation and Mitigation Strategy; TNF, tumor necrosis factor; VTE, venous thromboembolism.


V. New Biosimilars

Abrilada (new biosimilar)
(Adalimumab-afzb; Pfizer)
Class/route: TNF blocker; subcutaneous injection
Reference drug: Humira (adalimumab)
Indications: Treatment of adults with moderate-to-­severe rheumatoid arthritis; treatment of patients aged ≥4 years with moderate-to-severe polyarticular juvenile idiopathic arthritis; treatment of adults with psoriatic arthritis; treatment of adults with ankylosing spondylitis; treatment of moderate-to-severe Crohn’s disease in adults with an inadequate response to conventional therapy or who no longer respond to or are intolerant of infliximab; treatment of moderate-to-severe ulcerative colitis in adults with an inadequate response to immunosuppressants; treatment of moderate-to-severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and when other systemic therapies are less appropriate
Approval date: November 18, 2019

Avsola (new biosimilar)
(Infliximab-axxq; Amgen)
Class/route: TNF blocker; intravenous injection
Reference drug: Remicade (infliximab)
Indications: Treatment of moderate-to-severe Crohn’s disease in patients who have had an inadequate response to conventional therapy; treatment of adults with fistulizing Crohn’s disease; treatment of moderate-to-severe ulcerative colitis in patients with an inadequate response to conventional therapy; treatment, in combination with methotrexate, of moderately to severely active rheumatoid arthritis; treatment of active ankylosing spondylitis; treatment of psoriatic arthritis; treatment of adults with chronic severe plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are less appropriate
Approval date: December 6, 2019

Eticovo (new biosimilar)
(Etanercept-ykro; Samsung Bioepis)
Class/route: TNF blocker; subcutaneous injection
Reference drug: Enbrel (etanercept)
Indications: Treatment of rheumatoid arthritis; treatment of patients aged ≥2 years with polyarticular juvenile idiopathic arthritis; treatment of psoriatic arthritis; treatment of ankylosing spondylitis; treatment of patients aged ≥4 years with plaque psoriasis
Approval date: April 27, 2019

Hadlima (new biosimilar)
(Adalimumab-bwwd; Samsung Bioepis)
Class/route: TNF blocker; subcutaneous injection
Reference drug: Humira (adalimumab)
Indications: Treatment of adults with moderate-to-­severe rheumatoid arthritis; treatment of patients aged ≥4 years with moderate-to-severe juvenile idiopathic arthritis; treatment of psoriatic arthritis in adults; treatment of adults with ankylosing spondylitis; treatment of adults with moderate-to-severe Crohn’s disease with an inadequate response to conventional therapy or patients who no longer respond to or are intolerant of infliximab; treatment of adults with moderate-to-severe ulcerative colitis with an inadequate response to immunosuppressants; treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate
Approval date: July 23, 2019

Kanjinti (new biosimilar)
(Trastuzumab-anns; Amgen)
Class/route: HER2/neu receptor antagonist; intravenous injection
Reference drug: Herceptin (trastuzumab)
Indications: Adjuvant treatment of HER2-­overexpressing breast cancer; first-line treatment, in combination with paclitaxel, of HER2-overexpressing breast cancer, or as a single agent in patients who received chemotherapy for metastatic disease; treatment, in combination with chemotherapy, of HER2-overexpressing ­metastatic gastric or gastroesophageal junction ­adenocarcinoma
Approval date: June 13, 2019

Nyvepria (new biosimilar)
(Pegfilgrastim-apgf; Pfizer)
Class/route: G-CSF; subcutaneous injection
Reference drug: Neulasta (pegfilgrastim)
Indication: To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies who are receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia
Limitations of use: Not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem-cell transplantation
Approval date: June 11, 2020

Ontruzant (new biosimilar)
(Trastuzumab-dttb; Samsung Bioepis)
Class/route: HER2/neu receptor antagonist; intravenous injection
Reference drug: Herceptin (trastuzumab)
Indications: Adjuvant treatment of HER2-overexpressing breast cancer; first-line treatment, in combination with paclitaxel, of HER2-overexpressing breast cancer, or as a single agent in patients who received chemotherapy for metastatic disease; treatment, in combination with chemotherapy, of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
Approval date: January 21, 2019

Ruxience (new biosimilar)
(Rituximab-pvvr; Pfizer)
Class/route: CD20-directed cytolytic antibody; intravenous injection
Reference drug: Rituxan (rituximab)
Indications: Treatment of relapsed or refractory, low-grade or follicular, CD20-positive B-cell NHL as monotherapy; treatment of patients with follicular, CD20-positive B-cell NHL, in combination with first-line chemotherapy, and, in patients achieving a complete or partial response to rituximab plus chemotherapy, as maintenance monotherapy; treatment of nonprogressing (including stable disease), low-grade, CD20-positive B-cell NHL as monotherapy after first-line therapy with cyclophosphamide, vincristine, and prednisone; first-line treatment of diffuse large B-cell, CD20-positive NHL, in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone, or with other anthracycline-­based chemotherapy regimens; treatment of chronic lymphocytic leukemia; treatment, in combination with fludarabine and cyclophosphamide, of CD20-positive chronic lymphocytic leukemia; treatment, in combination with glucocorticoids, of granulomatosis with polyangiitis and microscopic polyangiitis
Approval date: July 23, 2019

Trazimera (new biosimilar)
(Trastuzumab-qyyp; Pfizer)
Class/route: HER2/neu receptor antagonist; intravenous injection
Reference drug: Herceptin (trastuzumab)
Indications: Adjuvant treatment of HER2-overexpressing breast cancer; first-line treatment, in combination with paclitaxel, of HER2-overexpressing breast cancer, or as a single agent in patients who received chemotherapy for metastatic disease; treatment, in combination with chemotherapy, of HER2-overexpressing ­metastatic gastric or gastroesophageal junction ­adenocarcinoma
Approval date: March 11, 2019

Ziextenzo (new biosimilar)
(Pegfilgrastim-bmez; Sandoz)
Class/route: G-CSF; subcutaneous injection
Reference drug: Neulasta (pegfilgrastim)
Indication: To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant febrile neutropenia
Limitations of use: Not indicated for mobilization of peripheral blood progenitor cells for hematopoietic stem-cell transplantation
Approval date: November 5, 2019

Zirabev (new biosimilar)
(Bevacizumab-bvzr; Pfizer)
Class/route: VEGF inhibitor; intravenous injection
Reference drug: Avastin (bevacizumab)
Indications: First-line treatment, in combination with chemotherapy, of metastatic colorectal cancer; second-­line treatment, in combination with chemotherapy, of metastatic colorectal cancer in patients whose disease progressed with a first-line bevacizumab-containing regimen; unresectable, locally advanced, recurrent or metastatic nonsquamous NSCLC; treatment of recurrent glioblastoma; treatment of metastatic renal-­cell carcinoma; treatment of persistent, recurrent, or metastatic cervical cancer
Limitations of use: Not indicated for adjuvant therapy of colon cancer; first-line treatment, in combination with carboplatin and paclitaxel, of unresectable, locally advanced, recurrent or metastatic nonsquamous NSCLC; recurrent glioblastoma in adults; treatment, in combination with interferon alfa, of metastatic renal-cell carcinoma; treatment, in combination with paclitaxel and cisplatin or with paclitaxel and topotecan, of persistent, recurrent, or metastatic cervical cancer
Approval date: June 27, 2019

 

G-CSF indicates granulocyte colony-stimulating factor; HER2, human epidermal growth factor receptor 2;
NHL, non-Hodgkin lymphoma; NSCLC, non–small-cell lung cancer; TNF, tumor necrosis factor; VEGF, vascular endothelial growth factor.

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