FDA Approvals, News & Updates
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 More ›
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 More ›
On September 20, 2022, the FDA approved sodium thiosulfate (Pedmark; Fennec Pharmaceuticals), an
inorganic sodium salt, for risk reduction of hearing loss (ototoxicity) associated with cisplatin treatment in children aged ≥1 month to 18 years with nonmetastatic solid tumors. Read More ›
On September 28, 2022, the FDA approved bevacizumab-adcd (Vegzelma; Celltrion), a VEGF inhibitor and a biosimilar to bevacizumab (Avastin), for the treatment of metastatic colorectal cancer; recurrent or metastatic non-squamous non–small-cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal-cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer. Read More ›
On September 30, 2022, the FDA accelerated the approval of futibatinib (Lytgobi; Taiho Oncology), a tyrosine kinase inhibitor, for the treatment of adults with previously treated unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (CCA) and FGFR2 gene fusion or other rearrangements. Read More ›
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.
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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 More ›
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 More ›
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 More ›
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 More ›