FDA Approvals, News & Updates

On March 27, 2021, the FDA approved idecabtagene vicleucel (Abecma; Bristol Myers Squibb/Bluebird Bio), a B-cell maturation antigen (BCMA)-directed, genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with multiple myeloma whose disease did not respond to, or recurred, after ≥4 lines of therapy. Idecabtagene vicleucel is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma. The FDA granted this indication orphan drug and breakthrough therapy designations.
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On February 9, 2021, the FDA approved a new indication for cemiplimab-rwlc (Libtayo; Regeneron/sanofi-aventis) for the treatment of locally advanced or metastatic basal-cell carcinoma (BCC) in patients who had received or are ineligible to receive a hedgehog inhibitor. The FDA granted cemiplimab a priority review and accelerated its approval for this indication.
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On March 3, 2021, the FDA approved a new indication for lorlatinib (Lorbrena; Pfizer), a third-generation ALK inhibitor, for the first-line treatment of patients with non–small-cell lung cancer (NSCLC) and ALK mutation.
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On March 5, 2021, the FDA approved a new indication for axicabtagene ciloleucel (Yescarta; Kite Pharma), a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed or refractory follicular lymphoma (FL) who have received ≥2 lines of systemic therapy. The FDA granted this indication a priority review as well as breakthrough therapy and orphan drug designations.
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On March 30, 2021, the FDA approved a new indication for daunorubicin and cytarabine (Vyxeos; Jazz Pharmaceuticals) for the treatment of pediatric patients aged ≥1 years with newly diagnosed, therapy-related acute myeloid leukemia (AML) or patients with AML and myelodysplasia-related changes. Daunorubicin and cytarabine is a liposomal combination of an anthracycline topoisomerase inhibitor (daunorubicin) and a nucleoside metabolic inhibitor (cytarabine).
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On February 5, 2021, the FDA approved umbralisib (Ukoniq; TG Therapeutics), an oral kinase inhibitor, for the treatment of adults with relapsed or refractory marginal-zone lymphoma (MZL) or with relapsed or refractory follicular lymphoma (FL). Umbralisib is indicated for MZL after ≥1 CD20-directed regimens, and for FL after ≥3 lines of systemic therapy.
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On February 5, 2021, the FDA approved lisocabtagene maraleucel (Breyanzi; Juno Therapeutics), a new CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with relapsed or refractory large B-cell lymphoma (LBCL) after ≥2 previous lines of systemic therapy. The FDA granted lisocabtagene maraleucel priority review, as well as breakthrough therapy, orphan drug, and regenerative medicine advanced therapy designations.
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On February 12, 2021, the FDA approved trilaciclib (Cosela; G1 Therapeutics), as a first-in-class cyclin-dependent kinase (CDK)4/6 inhibitor to reduce the frequency of chemotherapy-induced myelosuppression in adults with extensive-stage small-cell lung cancer, when used before a platinum plus etoposide regimen or a topotecan-containing regimen. Trilaciclib may prevent damage to bone marrow cells by inhibiting the CDK4/6 enzyme. The FDA granted trilaciclib priority review and a breakthrough therapy designation.
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On February 26, 2021, the FDA accelerated the approval of melphalan flufenamide (Pepaxto; Oncopeptides AB), an alkylating drug, for the treatment, in combination with dexamethasone, of adults with relapsed or refractory multiple myeloma who have received ≥4 lines of therapy and whose disease is triple-refractory to ≥1 proteasome inhibitors, 1 immunomodulatory drug, and 1 CD-38–directed monoclonal antibody.
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On December 18, 2020, the FDA approved selinexor (Xpovio; Karyopharm Therapeutics) in combination with bortezomib (Velcade) and dexamethasone for the treatment of adults with multiple myeloma after ≥1 previous therapies. The FDA granted this indication an orphan drug designation.
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