It Was Inevitable: FDA Inspection Delay Postpones BMS’s Liso-Cel Approval
Approval By Year-End Required For CVR Payout To Celgene Shareholders
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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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.
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.
FY2020 review highlights drop in inspections, preparations for growing backlog, and pandemic test of Janet Woodcock’s 21st Century proposition – developments that will likely reverberate in the years ahead.