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BMS And J&J CAR-Ts Flagged For Early Deaths Ahead of Back-To-Back FDA Advisory Panels

 
• By Sarah Karlin-Smith

Deaths that occurred before a patient randomized to one of the CAR-T products received that treatment don’t necessarily negate the FDA’s concerns, because risks associated with administration of treatment are “integral to the benefit-risk assessment,” the agency said.

Illustration of T cells attacking cancer cells
FDA advisors will vote on earlier indications for two CAR-T products in multiple myeloma 15 March • Source: Shutterstock

US Food and Drug Administration advisors will be asked to focus in on the higher rate of early deaths seen in subjects assigned to the CAR-T arms of both Janssen Biotech Inc.and Celgene Corporation/Bristol Myers Squibb Company’s supplemental biological applications as they evaluate whether the benefits of the products outweigh their risks for earlier use in multiple myeloma treatment.

The Oncologic Drug Advisory Committee will vote 15 March on whether the risk-benefit assessment for Janssen’s Carvykti (ciltacabtagene autoleucel) is...

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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.