FDA refuses review of bluebird/B-MS CAR-T therapy

13 May 2020

Shares in bluebird bio (Nasdaq: BLUE) were hit and those in Bristol-Myers Squibb (NYSE: BMY) were holding up after they received a Refusal to File letter from the US Food and Drug Administration (FDA) relating to their CAR-T therapy, idecabtagene vicleucel (ide-cel; bb2121).

Their Biologics License Application (BLA) seeking authorization for the treatment of heavily pre-treated relapsed and refractory multiple myeloma, was submitted in March.

Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control module of the BLA requires further detail to complete the review.

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