FDA Votes in Favor of Potential Myeloma Therapy Following Positive Results of Phase III Clinical Trial


Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients based on results from the pivotal Phase III KarMMa-3 study.

Image Credit: © LASZLO - stock.adobe.com

Image Credit: © LASZLO - stock.adobe.com

FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted positively that Bristol Myers Squibb’s and 2seventy bio’s Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma, according to a press release.1 The vote is based on positive results from the pivotal Phase III KarMMa-3 study, including the key secondary endpoint of overall survival.

“We are extremely pleased with the positive outcome of the ODAC meeting, which recognizes the favorable benefit/risk profile of Abecma, and based on results from the KarMMa-3 study, we are confident in the significant clinical benefit that Abecma delivers for patients with triple-class exposed relapsed or refractory multiple myeloma, an incurable disease with no clear effective standard of care in earlier lines of therapy,” said Anne Kerber, senior vice president, head of late clinical development, hematology, oncology, and cell therapy, Bristol Myers Squibb in the press release. “We look forward to working with the FDA as it completes review of our supplemental Biologics License Application (sBLA) in order to bring this potentially transformative therapy to more patients in need.”

“The favorable and supportive outcome of the ODAC meeting brings us another step closer to expanding the benefits of Abecma to myeloma patients earlier in their treatment course,” said Anna Truppel-Hartmann, senior vice president, clinical research and development, 2seventy bio in the press release. “We believe in the strength of the KarMMa-3 data and remain committed to increasing treatment options and improving outcomes for patients living with multiple myeloma.”

In December 2023, Bristol Myers Squibb and 2seventy bio announced the results of the open-label, global, randomized controlled study. At a median follow-up of 30.9 months, significantly improved progression-free survival was maintained with Abecma compared to standard regimens, with a 51% reduction in the risk of disease progression or death.2

Abecma was recently approved in Japan and Switzerland for patients with relapsed and/or refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. It is the first CAR T cell therapy to receive regulatory approval for use in earlier lines of therapy for patients with relapsed or refractory multiple myeloma. The therapy has also received a positive opinion from EMA’s Committee for Medicinal Products for Human Use.

This recent recommendation from ODAC will be considered by FDA during its ongoing review of the sBLA for Abecma.

“With patients becoming triple-class exposed earlier in the multiple myeloma treatment paradigm, it is critical that new treatment options with the potential to improve long-term outcomes are available as early as possible,” said Sagar Lonial, MD, FACP, professor and chair, department of hematology & medical oncology, Emory University School of Medicine, chief medical officer, Winship Cancer Institute of Emory University in the press release. “We are thankful that today’s ODAC vote recognizes this unmet need and helps to advance ide-cel, a novel treatment option with demonstrated clinically meaningful benefit, for patients with triple-class exposed relapsed or refractory multiple myeloma.”


1. FDA Advisory Committee Votes in Favor of Bristol Myers Squibb’s and 2seventy bio’s Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy. News release. March 15, 2024. Accessed March 18, 2024. https://news.bms.com/news/details/2024/FDA-Advisory-Committee-Votes-in-Favor-of-Bristol-Myers-Squibbs-and-2seventy-bios-Abecma-for-Triple-Class-Exposed-Multiple-Myeloma-in-Earlier-Lines-of-Therapy/default.aspx

2. Abecma Delivers Sustained Progression-Free Survival Versus Standard Regimens in Earlier Lines of Therapy for Relapsed and Refractory Multiple Myeloma Based on Longer-Term Follow-up from KarMMa-3. News release. December 11, 2023. Accessed March 18, 2024. https://news.bms.com/news/corporate-financial/2023/Abecma-Delivers-Sustained-Progression-Free-Survival-Versus-Standard-Regimens-in-Earlier-Lines-of-Therapy-for-Relapsed-and-Refractory-Multiple-Myeloma-Based-on-Longer-Term-Follow-up-from-KarMMa-3/default.aspx

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