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