It Was Inevitable: FDA Inspection Delay Postpones BMS’s Liso-Cel Approval
Approval By Year-End Required For CVR Payout To Celgene Shareholders
Executive Summary
Bristol Myers Squibb confirmed that approval for lisocabtagene maraleucel (liso-cel) will be delayed by the US FDA’s COVID-19-related restrictions on travel for manufacturing facility inspectors.
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Preparing For The Return Of US FDA Inspections
Compared to FY2019, FDA data show agency inspections of OTC and Rx drug manufacturing facilities in FY2020 fell 60%. As pandemic continues in FY2021, inspection rate will remain depressed, and it remains unclear how the agency will reduce the backlog without resorting to remotely conducted inspections.
EU Fast-Track Fail For Another BMS CAR-T Cell Therapy
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.