FDA Approvals, News & Updates

On December 1, 2022, the FDA approved olutasidenib (Rezlidhia; Forma Therapeutics) capsules, an oral IDH1 inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) and a susceptible IDH1 mutation, as detected by an FDA-approved test. Read Article ›

On November 14, 2022, the FDA accelerated the approval of mirvetuximab soravtansine-gynx (Elahere; ImmunoGen), an intravenous (IV) folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate, for the treatment of adults with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1 to 3 previous systemic treatments, regardless of previous use of bevacizumab (Avastin). Read Article ›

On October 25, 2022, the FDA accelerated the approval of teclistamab-cqyv (Tecvayli; Janssen Biotech), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who received ≥4 previous lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. Read Article ›

On October 21, 2022, the FDA approved tremelimumab (Imjudo; AstraZeneca), a CTLA-4 monoclonal antibody, in combination with durvalumab (Imfinzi; AstraZeneca), a PD-L1 inhibitor, for the treatment of adults with unresectable hepatocellular carcinoma (HCC). Read Article ›

On November 10, 2022, the FDA approved this new immunotherapy, in combination with the PD-L1 inhibitor durvalumab (Imfinzi; AstraZeneca) and platinum-based chemotherapy, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and no EGFR or ALK genomic alterations. Read Article ›

On November 10, 2022, the FDA approved brentuximab vedotin (Adcetris; Seagen) in combination with a chemotherapy regimen of doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC) for treatment-naïve pediatric patients aged ≥2 years with high-risk classical Hodgkin lymphoma. Read Article ›

On November 8, 2022, the FDA approved a new indication for cemiplimab-rwlc (Libtayo; Regeneron), a PD-1 inhibitor, in combination with platinum-based chemotherapy, for the treatment of adults with advanced NSCLC and no EGFR, ALK, or ROS1 aberrations. Read Article ›

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 Article ›

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 Article ›

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 Article ›