FDA ODAC Backs Ide-Cel in Multiple Myeloma, Highlighting KarMMa-3 Trial Results

The FDA Oncologic Drugs Advisory Committee (ODAC) voted 8 to 3 in favor of using intravenous infusion of idecabtagene vicleucel (ide-cel; Abecma) for patients with pretreated relapsed/refractory multiple myeloma. This followed the FDA’s acceptance of a supplemental biologics license application for ide-cel based on results from the phase 3 KarMMa-3 trial.

In the trial, 254 patients were treated with ide-cel and 132 received standard care. Patients underwent lymphodepletion and were then given an infusion of ide-cel. The median follow-up was 18.6 months, with ide-cel showing a median PFS of 13.3 months compared to 4.4 months for standard care. The ide-cel group also had higher response rates, including stringent complete responses, and a greater minimal residual disease negativity rate. However, the treatment came with significant adverse effects (AEs), including grade 3/4 AEs in 93% of the ide-cel group compared to 75% in standard care. Cytokine release syndrome occurred in 88% of ide-cel patients, with two grade 5 events.

Reference: Pelosci A. Ide-Cel Receives Favorable ODAC Vote for R/R Multiple Myeloma. Cancer Network. Updated March 15, 2024. Accessed April 5, 2024. https://www.cancernetwork.com/view/ide-cel-receives-favorable-unfavorable-odac-vote-for-r-r-multiple-myeloma

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