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A BCMA Setback For Bristol And Bluebird With FDA Refuse-To-File Letter

 
• By Jessica Merrill

The US FDA took issue with the CMC portion of the BLA for the BCMA-targeted therapy idecabtagene vicleucel for multiple myeloma. An approval is tied to a $9 CVR for Celgene shareholders. 

NO rubber stamp
FDA rejected Bristol/bluebird's BLA filing

The US Food and Drug Administration issued a refuse-to-file letter for the BCMA-targeting CAR-T therapy idecabtagene vicleucel (ide-cel) for relapsed/refractory multiple myeloma, partners Bristol Myers Squibb Co. and bluebird bio Inc. announced on 13 May. But while this threatens the timeline for a contingent value right payment to Celgene Corp. investors, it still leaves the door open to meet the deadline.

The companies said the FDA cited problems with the chemistry, manufacturing and controls section of the biologics license application and...

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