Fast-Track Loss In EU For Celgene’s CAR-T Cell Therapy
Liso-cel Review Will Take Longer Than Anticipated in EU As Well As In US
The review of liso-cel, Celgene/Bristol Myers Squibb's potential new CAR T-cell therapy for R/R DLBCL, is facing regulatory setbacks in the EU as well as in the US.
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The US major won a positive opinion from the EU CHMP for Breyanzi with hopes the advantage of outpatient administration could help combat the lack of market impetus for CAR-T therapies.
Several new drugs are now on track for an EU marketing authorization after getting the EMA’s thumbs up this week.
Pfizer’s oral COVID-19 antiviral drug and Celgene/Bristol Myers Squibb’s CAR-T for treating large B-cell lymphoma are among 11 new drugs on which the EMA is set to adopt recommendations on their possible EU-wide approval.