FDA Approvals, News & Updates
On September 14, 2023, the FDA approved new and updated indications for temozolomide (Temodar; Merck) capsules and injection, an alkylating drug, including for the adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma, and for the treatment of adults with refractory anaplastic astrocytoma. The previously approved indication for the treatment of adults with newly diagnosed glioblastoma, concomitant with radiotherapy, then as maintenance treatment, remains unchanged. Read More ›
On August 14, 2023, the FDA accelerated the approval of elranatamab-bcmm (Elrexfio; Pfizer), a bispecific B-cell maturation antigen–directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 previous lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Read More ›
On August 9, 2023, the FDA accelerated the approval of talquetamab-tgvs (Talvey; Janssen Biotech), a bispecific GPRC5D-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Read More ›
On August 11, 2023, the FDA accelerated the approval of the fixed-dose combination of niraparib and abiraterone acetate (Akeega; Janssen Biotech), with prednisone, for the treatment of adults with deleterious or suspected deleterious BRCA-mutated, castration-resistant prostate cancer, as determined by an FDA-approved test. The FDA granted this approval priority review. Read More ›
On August 9, 2023, the FDA granted regular approval to pralsetinib (Gavreto; Genentech), a kinase inhibitor of wild-type RET and oncogenic RET fusions and mutations, for the treatment of adults with metastatic non–small cell lung cancer and RET fusion–positive gene mutation, as detected by an FDA-approved test. Read More ›
On June 15, 2023, the FDA accelerated the approval of glofitamab-gxbm (Columvi; Genentech), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after ≥2 lines of systemic therapy. Read More ›
On May 19, 2023, the FDA accelerated the approval of epcoritamab-bysp (Epkinly; Genmab US), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma after ≥2 lines of systemic therapy. The FDA granted this application priority review. Read More ›
On May 31, 2023, the FDA approved a new indication for olaparib (Lynparza; AstraZeneca), a poly (ADP-ribose) polymerase inhibitor, in combination with abiraterone (Zytiga; Astellas) and prednisone (or prednisolone) for adults with deleterious or suspected deleterious BRCA mutation–positive, metastatic castration-resistant prostate cancer as determined by an FDA-approved test. Read More ›
On April 17, 2023, the FDA approved omidubicel-onlv (Omisirge; Gamida Cell), a substantially modified allogeneic cord blood–based cell therapy, to quicken the recovery of neutrophils in the body and reduce the risk for infection in adults and pediatric patients aged ≥12 years with hematologic malignancies who have a planned umbilical cord blood transplant after a myeloablative conditioning regimen, such as radiation or chemotherapy. Read More ›
On April 19, 2023, the FDA approved polatuzumab vedotin (Polivy; Genentech), a CD79b-directed antibody–drug conjugate, in combination with rituximab (Rituxan or a biosimilar; Genentech), cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified, or high-grade B-cell lymphoma and who have an International Prognostic Index score of ≥2. Read More ›