BioPharma Dive March 15, 2024
At an advisory meeting, a majority of outside experts agreed that the apparent benefits of treatment with Carvykti and Abecma outweigh the risks.
Advisers to the Food and Drug Administration have endorsed the use of two cellular medicines for multiple myeloma earlier in a patient’s disease, overlooking safety concerns raised by agency reviewers earlier this week.
The advisory committee on Friday voted unanimously, 11-0, that the benefits of Johnson & Johnson and Legend Biotech’s Carvykti outweighed the risks when administered to patients as early as after their first relapse. They cast a narrower, but similarly positive vote, 8-3, for Bristol Myers Squibb’s Abecma.
The impact ot treatment “is significant and offers our patients a chance of significant time off...
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