EU Fast-Track Fail For Another BMS CAR-T Cell Therapy

EMA Review Of Ide-Cel Reverts To Standard Timelines; Orva-Cel Development Program Scrapped

Bristol Myers Squibb says it is common for cell and gene therapies to revert to the standard timetable as ide-cel follows liso-cel in losing its accelerated assessment status at the European Medicines Agency. Separately, the company has discontinued development of orva-cel, a CAR-T cell therapy that was earlier in the development pipeline.

Time
Fast-track review can shorten the time to market for new drugs • Source: Shutterstock

A second CAR-T cell therapy from Bristol Myers Squibb that is under review at the European Medicines Agency has lost its fast-track status.

Lisocabtagene maraleucel (liso-cel) reverted to standard review timelines a couple of months ago and now idecabtagene vicleucel (ide-cel), from BMS...

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