SPY304.32+1.35 0.45%
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Bristol Myers Squibb And bluebird bio Say Upon Preliminary Review, FDA Determined That The Chemistry, Manufacturing And Control Module Of The BLA For Idecabtagene Vicleucel Requires Further Detail To Complete The Review

PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) and bluebird bio, Inc. (NASDAQ:BLUE) today announced that the companies received a Refusal to File letter from the U.S. Food and

Benzinga · 05/13/2020 11:00

PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) and bluebird bio, Inc. (NASDAQ:BLUE) today announced that the companies received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020.

Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the BLA requires further detail to complete the review. No additional clinical or non-clinical data have been requested or are required. Bristol Myers Squibb is planning to resubmit the BLA no later than the end of July 2020.