FDA Approvals, News & Updates
On December 9, 2022, the FDA approved atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, for patients aged ≥2 years with unresectable or metastatic alveolar soft-part sarcoma (ASPS), a type of soft-tissue sarcoma. The FDA granted atezolizumab breakthrough therapy and orphan drug designations for this indication. Read More ›
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 More ›
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 More ›
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 More ›
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 More ›
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 More ›
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 More ›
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 More ›
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 More ›
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 More ›