Bristol-Myers' CAR-T cell therapy meets with FDA delay

6 May 2020

The submission of additional information, upon the request of the US regulator, has delayed the action date for Bristol-Myers Squibb’s (NYSE: BMY) CAR-T cell candidate lisocabtagene maraleucel (liso-cel).

The firm has submitted an application to market the CD19-directed therapy for adults with relapsed or refractory large B-cell lymphoma, in the third-line setting.

The new Prescription Drug User Fee Act (PDUFA) action date is November 16, 2020.

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