March 15, 2024 Meeting of the Oncologic Drugs Advisory Committee (ODAC)

During the morning session, the Committee will discuss supplemental biologics license application (sBLA) 125746.74 for CARVYKTI (ciltacabtagene autoleucel), suspension for intravenous infusion, submitted by Janssen Biotech, Inc. The proposed indication for this product is for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least one prior line of therapy, including a proteasome inhibitor, and an immunomodulatory agent, and are refractory to lenalidomide. The Committee will have a general discussion focused on the overall survival data in the Study MMY3002 (CARTITUDE-4) and the risk and benefit of ciltacabtagene autoleucel in the intended population. During the afternoon session, the Committee will discuss sBLA 125736.218 for ABECMA (idecabtagene vicleucel), suspension for intravenous infusion, submitted by Celgene Corp., a Bristol-Myers Squibb Co. The proposed indication is for the treatment of adult patients with relapsed or refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The Committee will have a general discussion focused on the overall survival data in the Study MM-003 (KarMMa-3) and the risk and benefit of idecabtagene vicleucel in the intended population.