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# Panel to Review Carvykti and Abecma sBLAs
- URL: https://www.fdaweb.com/panel-to-review-carvykti-and-abecma-sblas/
- Published: 2024-02-02T12:00:00.000Z
- Updated: 2026-09-14T14:22:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156282

*Federal Register* notice: FDA is announcing a 3/15 Oncologic Drugs Advisory Committee meeting. Panel members in the morning are scheduled to discuss a Janssen Biotech supplemental BLA for Carvykti (ciltacabtagene autoleucel) and its use in treating adult patients with relapsed or refractory multiple myeloma and who have received at least one prior line of therapy, including a proteasome inhibitor, and an immunomodulatory agent, and are refractory to lenalidomide. The discussion is intended to focus on overall survival data in Study MMY3002 (CARTITUDE-4) and the risk and benefit of ciltacabtagene autoleucel in the intended population. During the afternoon session, members will discuss a Celgene sBLA for Abecma (idecabtagene vicleucel) for treating adult patients with relapsed or refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Their discussion will be focused on overall survival data in the Study MM-003 (KarMMa-3) and the risk and benefit of idecabtagene vicleucel in the intended population. To view the notice, click [here](https://public-inspection.federalregister.gov/2024-02229.pdf?ref=fdaweb.com).