FDA Declines Review of BMS’ CAR T Therapy Due to MfgBy
Bristol Myers Squibb (BMS) and bluebird bio, a Cambridge, Massachusetts-based clinical-stage gene-therapy company, have received a Refusal to File Letter from the US Food and Drug Administration (FDA) regarding the biologics license application (BLA) for idecabtagene vicleucel, a chimeric antigen receptor (CAR) T‑cell immunotherapy for treating relapsed and refractory multiple myeloma.
The companies had submitted the BLA in March 2020. Upon preliminary review, the FDA determined that the chemistry, manufacturing and control module of the BLA requires further detail to complete the review. No additional clinical or non-clinical data have been requested or are required. BMS says it is planning to resubmit the BLA no later than the end of July 2020.
BMS gained idecabtagene vicleucel through its $74-billion acquisition of Celgene in 2019.