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FDA approves idecabtagene vicleucel for triple-class-exposed RRMM
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On April 5, 2024, the U.S. Food and Drug Administration granted approval to idecabtagene vicleucel (ide-cel) for the treatment of triple-class-exposed relapsed/refractory multiple myeloma (RRMM) after two or more prior therapies, including an immunomodulatory agent (IMiD), proteasome inhibitor (PI), and an anti-CD38 antibody.1
This approval was based on data from the phase III KarMMa-3 (NCT03651128) clinical trial.1 The Multiple Myeloma Hub has previously reported on the trial design of KarMMa-3 here.
KarMMa-3 pivotal data1
- A total of 254 patients were randomized for treatment with ide-cel and 132 to a comparator arm consisting of standard regimens.
- At a median follow up of 15.9 months:
- Median progression-free survival (PFS) was significantly higher in the ide-cel arm at 13.3 months vs 4.4 months in the control arm.
- An overall response rate of 71% was observed with ide-cel, and a complete or stringent complete response rate of 39%.
- Median duration of overall response was 14.8 months in the ide-cel arm, and duration of complete/better response was 20 months.
- U.S. FDA Approves Bristol Myers Squibb and 2seventy bio’s Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy. https://www.businesswire.com/news/home/20240403030392/en/U.S.-FDA-Approves-Bristol-Myers-Squibb-and-2seventy-bio%E2%80%99s-Abecma-for-Triple-Class-Exposed-Relapsed-or-Refractory-Multiple-Myeloma-After-Two-Prior-Lines-of-Therapy. Published Apr 5, 2024. Accessed Apr 8, 2024.
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