ODAC to Discuss CARs Free

The FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will meet on March 15 to discuss applications from Janssen Biotech and Celgene to use their chimeric antigen receptor (CAR) T-cell therapies—ciltacabtagene autoleucel (cilta-cel; Carvykti) and idecabtagene vicleucel (ide-cel; Abecma), respectively—earlier in the treatment regimen for multiple myeloma (see https://public-inspection.federalregister.gov/2024-02229.pdf). The committee will focus on overall survival data from the CARTITUDE-4 and KarMMa-3 trials, respectively, as well as the risks and potential benefits associated with each treatment. Last month, based on reports that about two dozen patients who received CAR T-cell therapies developed secondary T-cell cancers, the FDA called for the addition of boxed warnings on all such products, including cilta-cel and ide-cel.