Bristol Myers Squibb and 2seventy bio’s Abecma gets positive FDA committee vote for multiple myeloma

In a significant development in the healthcare industry, Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced a favorable vote by the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) regarding Abecma (idecabtagene vicleucel). The committee’s 8-3 vote supports the therapy’s benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma, based on the Phase 3 KarMMa-3 study results, which include the key secondary endpoint of overall survival.

This recommendation will play a crucial role in the FDA’s ongoing review of the supplemental Biologics License Application (sBLA) for Abecma. While the FDA has yet to set a new target action date for the sBLA review, this step marks a pivotal moment in the quest to offer a potentially transformative therapy to a broader patient demographic.

Anne Kerber, senior vice president, head of Late Clinical Development, Hematology, Oncology and Cell Therapy at Bristol Myers Squibb, expressed satisfaction with the ODAC’s decision, highlighting the anticipated clinical benefit of Abecma for patients with this incurable disease, which lacks an effective standard of care in earlier therapy lines. Similarly, Anna Truppel-Hartmann, senior vice president of Clinical Research and Development at 2seventy bio, underscored the significance of expanding Abecma’s benefits to myeloma patients sooner in their treatment journey.

The ODAC’s positive vote follows a review of interim overall survival data from the KarMMa-3 study, presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition. The discussion emphasized the urgency of making new treatment options available to improve long-term outcomes for patients who become triple-class exposed earlier in the multiple myeloma treatment paradigm.

Sagar Lonial, MD, FACP, professor and chair of the Department of Hematology & Medical Oncology at Emory University School of Medicine and chief medical officer at Winship Cancer Institute of Emory University, thanked the ODAC for recognizing the unmet need and advancing a novel treatment option that has shown clinically meaningful benefit.

Abecma’s journey includes recent approvals in Japan and Switzerland for patients with relapsed and/or refractory multiple myeloma who have received at least two prior therapies. It stands as the first CAR T cell therapy approved for use in earlier lines of therapy for this patient group. Moreover, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for expanding Abecma’s indication to include treatment for patients with triple-class exposed relapsed and refractory multiple myeloma after at least two prior therapies, highlighting its growing global impact.