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# BMS/Bluebird Resubmit BLA for Multiple Myeloma
- URL: https://www.fdaweb.com/bms-bluebird-resubmit-bla-for-multiple-myeloma/
- Published: 2020-07-31T12:00:00.000Z
- Updated: 2026-09-14T16:23:22.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147330

Bristol Myers Squibb and Bluebird Bio have re-filed their BLA for idecabtagene vicleucel, indicated for treating patients with heavily pre-treated relapsed and refractory multiple myeloma. In May, FDA sent a refusal to file letter, telling the company that the BLA’s chemistry, manufacturing and control (CMC) module requires further detail to complete the review, the companies say, adding that no additional clinical or non-clinical data have been requested.  

Idecabtagene vicleucel is described as a B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy intended for treating adult patients with multiple myeloma who have received at least three prior therapies. The companies say the latest submission now provides further details on the CMC module to address the outstanding regulatory requests. Overall, the submission is based on results from the pivotal Phase 2 KarMMa study evaluating the therapy’s efficacy and safety in relapsed and refractory multiple myeloma patients exposed to an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Data indicated that the study met its primary endpoint of overall response rate, and the key secondary endpoint of complete response rate in the patient population treated with the therapy, they say.