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