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.Â
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.Â
FDA granted HDP-101 orphan drug designation in multiple myeloma.Â
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.Â
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.
The FDA Oncologic Drugs Advisory Committee voted 12:2 to recommend approval of the drug imetelstat for a myelodysplastic syndrome indication.
FDA has granted accelerated approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor CAR T-cell therapy for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. Â
