FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
A coalition of health and physician groups earlier this week filed a lawsuit seeking to force FDA to finalize a long-delayed final rule banning menthol cigarettes.
FDA approved Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial (The Cancer Letter, March 22, 2024).
FDA issued Complete Response Letters for the Biologics License Application for odronextamab in relapsed/refractory follicular lymphoma and in R/R diffuse large B-cell lymphoma, each after two or more lines of systemic therapy.
FDA approved Elahere (mirvetuximab soravtansine-gynx) for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
FDA granted HDP-101 orphan drug designation in multiple myeloma.
The FDA Oncologic Drugs Advisory Committee voted overwhelmingly in favor of expanding the indications of two chimeric antigen receptor engineered T-cell therapies for multiple myeloma that showed improvement in progression-free survival, but also reported a higher number of early deaths on the experimental arm.
FDA granted accelerated approval to Iclusig (ponatinib) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
FDA has approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence.
When conducting a randomized clinical trial of a treatment regimen based on an immune checkpoint inhibitor, trial sponsors should include overall survival as an endpoint, FDA officials say.
