FDA Sends Refusal to File Letter to Bristol Myers For Multiple Myeloma Treatment

May 14, 2020

Bristol Myers Squibb and Bluebird Bio received a Refusal to File letter from the FDA for their multiple myeloma treatment idecabtagene vicleucel.

The agency determined that the chemistry, manufacturing and control (CMC) module of the BLA requires more detail to complete the review. The companies are not required to submit additional clinical or nonclinical data.

Bristol Myers Squibb is planning to resubmit the BLA no later than the end of July.

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