FDA extends action date for Bristol-Myers’ liso-cel to November 16

Citing a major amendment to its filing, the FDA has extended its action date for Bristol-Myers Squibb’s (NYSE:BMY) marketing application seeking approval of CAR T therapy lisocabtagene maraleucel (liso-cel) for adults with relapsed/refractory large B-cell lymphoma after at least prior lines of therapy to November 16 (from August 17).

The extension is standard operating procedure when there is a major amendment to an application to allow more time for review. In this case, it was additional information requested by the agency.

An FDA nod by year-end is one of the required remaining milestones of the Contingent Value Rights (CVRs) issued when the Celgene deal closed in Q4 2019. The other is the U.S. approval of idecabtagene vicleucel (ide-cel) by March 31, 2021.

https://seekingalpha.com/news/3569928-fda-extends-action-date-for-bristol-myers-liso-cel-to-november-16