FDA Approvals, News & Updates

On August 11, 2022, the FDA accelerated the approval of the antibody–drug conjugate fam-trastuzu­mab deruxtecan-nxki (Enhertu; Daiichi Sankyo) for the treatment of adult patients with unresectable or metastatic non–small-cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as determined by an FDA-­approved test, and who have received a previous systemic therapy. Read Article ›

On August 5, 2022, the FDA approved darolutamide (Nubeqa; Bayer) tablets, in combination with docetaxel, for the treatment of adult patients with metastatic hormone-sensitive prostate cancer. The FDA granted this new indication a priority review. Read Article ›

On July 14, 2022, the FDA approved the multikinase inhibitor crizotinib (Xalkori; Pfizer) for the treatment of unresectable, recurrent, or refractory inflammatory myofibroblastic tumors with anaplastic lymphoma kinase (ALK) mutation in patients aged ≥1 years. The FDA granted crizotinib an orphan drug designation for this indication. Read Article ›

On June 24, 2022, the FDA approved the CD19-directed chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi; Juno Therapeutics) for the treatment of adults with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal LBCL, and grade 3B follicular lymphoma. Read Article ›

On June 22, 2022, the FDA accelerated the approval of dabrafenib (Tafinlar; Novartis), a mutation inhibitor, in combination with trametinib (Mekinist; GlaxoSmithKline), a MEK inhibitor, for the treatment of unresectable or metastatic solid tumors and BRAF V600E mutation in adults and pediatric patients aged ≥6 years who have had disease progression after receiving previous treatment. Read Article ›

On June 30, 2022, the FDA issued a new boxed warning for duvelisib (Copiktra; Secura Bio) about the increased risk for serious side effects and death with this PI3K inhibitor, based on the result of the DUO clinical trial. Read Article ›

On May 27, 2022, the FDA accelerated the approval of a new indication for the CD19-directed CAR T-cell therapy tisagenlecleucel (Kymriah; Novartis) for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. The FDA granted this indication an orphan drug designation. Read Article ›

On May 25, 2022, the FDA accelerated the approval of ivosidenib tablets (Tibsovo; Servier Pharmaceuticals) in combination with azacitidine tablets (Onureg; Celgene) for newly diagnosed acute myeloid leukemia (AML) and a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients aged ≥75 years, or patients with comorbidities that preclude the use of intensive induction chemotherapy. Read Article ›

On May 20, 2022, the FDA accelerated the approval of a new indication for azacitidine injection (Vidaza; Celgene) for the treatment of pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). Read Article ›

On May 4, 2022, the FDA granted a regular full approval for fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo) for adults with unresectable or metastatic HER2-positive breast cancer who had previously received an anti-HER2 regimen in the metastatic or the neoadjuvant or adjuvant setting whose disease recurred during or within 6 months of completing therapy, based on the confirmatory DESTINY-Breast03 clinical trial. Read Article ›

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