BioCentury
ARTICLE | Regulation

Extended review of Bristol’s CAR T leaves little daylight for CVR from Celgene deal

May 6, 2020 5:02 PM UTC
Updated on May 13, 2020 at 11:41 AM UTC

The latest delay in the regulatory timeline for BMS’s CAR T therapy liso-cel means that any further snags would jeopardize a potential payout worth up to $6.8 billion to Celgene’s shareholders that was associated with the pharma’s takeout of that company last year.

Bristol Myers Squibb Co. (NYSE:BMY) said Wednesday that FDA will extend its review of lisocabtagene maraleucel by three months, giving it a new PDUFA date of Nov. 16. BMS said FDA requested additional information for liso-cel’s BLA, which constituted a major amendment and required additional time to review...