It Was Inevitable: FDA Inspection Delay Postpones BMS’s Liso-Cel Approval

Bristol Myers Squibb Company confirmed on 16 November what many analysts and investors feared was inevitable – that the US Food and Drug Administration was not able to inspect the second of two manufacturing sites for lisocabtagene maraleucel (liso-cel) in time to inform an approval decision, putting in jeopardy a payout to Celgene Corporation shareholders tied to on-time approvals of three new products under the two companies’ merger agreement.

Analysts anticipated earlier this month that approval would be delayed after BMS executive vice president and chief medical officer Samit Hirawat told the company’s third quarter earnings call on 5 November that due to travel restrictions for inspectors due to the pandemic the FDA had not scheduled an inspection for the final manufacturing facilities for liso-cel, a CD19-targeting chimeric antigen receptor T-cell (CAR-T)