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Bristol Myers Squibb Says Was Informed By FDA That Its Review Of The Biologics License Application For Lisocabtagene Maraleucel Will Not Be Completed By Nov. 16 PDUFA Date; FDA Was Unable To Conduct Inspection Due To COVID-19 Travel Restrictions

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that its review of the Biologics License Application (BLA) for

· 11/16/2020 16:23

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that its review of the Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies will not be completed by the Prescription Drug User Fee Act (PDUFA) action date of November 16, 2020.

The FDA was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic. Therefore, the FDA is deferring action on the application until the inspection can be completed. The application remains under review. The FDA did not provide a new anticipated action date.