FDA Approvals, News & Updates

On September 21, 2022, the FDA accelerated the approval of selpercatinib (Retevmo; Eli Lilly), a selective RET kinase inhibitor, for the treatment of all locally advanced or metastatic solid tumors with a RET gene fusion in patients whose disease progressed during or after systemic treatment or who have no alternative treatment options. Read Article ›

On September 2, 2022, the FDA accelerated the approval of durvalumab (Imfinzi; AstraZeneca), a PD-L1 inhibitor, in combination with gemcitabine and cisplatin, for adults with locally advanced or metastatic biliary tract cancer. Read Article ›

On August 26, 2022, the FDA accelerated the approval of pemigatinib (Pemazyre; Incyte), a tyrosine kinase inhibitor, for the treatment of relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangements in adults. Pemigatinib received a breakthrough therapy designation for this indication. Read Article ›

On August 24, 2022, the FDA accelerated the approval of ibrutinib (Imbruvica; Pharmacyclics), a Bruton tyrosine kinase inhibitor, for chronic graft-versus-host disease (GVHD) in pediatric patients aged ≥1 year whose disease did not respond to ≥1 lines of systemic therapy. Concomitantly, the FDA approved a new oral suspension formulation of ibrutinib for use in this patient population. Read Article ›

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 ›