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# FDA Delaying BMS Liso-Cel Action Date
- URL: https://www.fdaweb.com/fda-delaying-bms-liso-cel-action-date/
- Published: 2020-11-18T12:00:00.000Z
- Updated: 2026-09-14T16:37:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148114

FDA has informed Bristol-Myers Squibb that it will not complete its review of the company’s BLA for lisocabtagene maraleucel (liso-cel) by the 11/16 PDUFA action date. The drug is indicated for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. The company [says](https://www.businesswire.com/news/home/20201116006018/en/Bristol-Myers-Squibb-Provides-Regulatory-Update-on-Lisocabtagene-Maraleucel-liso-cel?ref=fdaweb.com) the agency was unable to inspect a third-party manufacturing facility in Texas during the review cycle due to the Covid-19 pandemic. FDA deferred action until the inspection can be completed and did not set a new anticipated action date, BMS says. Company officials say they continue to work with FDA on the BLA review.