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US FDA staff flag safety concerns from J&J, Bristol's CAR-T therapies
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US FDA staff flag safety concerns from J&J, Bristol's CAR-T therapies
Mar 13, 2024 6:26 AM

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 ( JNJ ) and

Bristol-Myers Squibb's ( BMY ) 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.

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