MedPage Today March 16, 2024
— Cilta-cel, ide-cel win support despite concerns about early mortality risk
Two CAR T-cell therapies for multiple myeloma won favorable recommendations for earlier use in the disease during a day-long meeting of the FDA Oncologic Drugs Advisory Committee (ODAC).
By an 11-0 vote, ODAC recommended that FDA approve ciltacabtagene autoleucel (cilta-cel, Carvykti) for use as second-line therapy in certain patients with myeloma. Later in the day, the panel voted 8-3 in favor of approving idecabtagene ciloleucel (ide-cel, Abecma) for second-line treatment. The FDA is not bound by advisory committee decisions but usually follows the recommendations.
The favorable recommendations followed considerable discussion about an early mortality risk — and the potential cause — seen in pivotal trials of both therapies. In...
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