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FDA to focus on ‘early deaths’ in meeting on broader CAR-T use in myeloma

March 13, 2024


Two cellular medicines for multiple myeloma were associated with an increased risk of early death in clinical testing, raising questions about whether they should be earlier in a patient’s disease, Food and Drug Administration scientists wrote in a briefing document published on Wednesday.

On Friday, the FDA will convene a panel of experts to discuss whether the two cell therapies — Legend Biotech and Johnson & Johnson’s Carvykti, and Bristol Myers Squibb’s Abecma — should be used as early as after a patient’s first relapse.

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