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

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