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FDA Approvals, News & Updates

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 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 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 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 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 ›

On April 3, 2023, the FDA accelerated the approval of a new indication for enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, with pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. Read More ›

On March 22, 2023, the FDA granted accelerated approval to retifanlimab-dlwr (Zynyz; Incyte Corporation), a programmed cell death 1–blocking antibody, for the treatment of adult patients with metastatic or recurrent locally advanced Merkel-cell carcinoma. Read More ›

On March 16, 2023, the FDA approved dabrafenib (Tafinlar; Novartis) in combination with trametinib (Mekinist; Novartis) for the treatment of pediatric patients aged ≥1 year with low-grade glioma that harbors a BRAFV600E mutation and who require systemic therapy. Read More ›

On March 3, 2023, the FDA approved abemaciclib (Verzenio; Eli Lilly) plus endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer at high risk for recurrence. Read More ›

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