US FDA staff flag safety concerns from J&J, Bristol's CAR-T therapies
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March 13 (Reuters) - The U.S. Food and Drug Administration's staff reviewers on Wednesday raised safety concerns over the use of Johnson & Johnson's and Bristol-Myers Squibb's cancer therapies as earlier treatments for blood cancer patients.
Staff reviewers said that the pattern of early deaths observed in patients treated with both the therapies in their respective trials raised uncertainty about their overall survival benefit.
The therapies - J&J's Carvykti and Bristol Myers' Abecma - are approved by the FDA to treat patients with multiple myeloma who have received at least four prior lines of treatment.
(Reporting by Sneha S K and Bhanvi Satija in Bengaluru; Editing by Shailesh Kuber)
