Monday, July 15, 2024

An Immunotherapy for Multiple Myeloma, Abecma, Receives Positive Recommendation from ODAC

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Abecma, a B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR)-T cell immunotherapy, has been recommended by the Oncologic Drugs Advisory Committee (ODAC). The recommendation supports the positive benefit/risk profile of the therapy, based on the Phase III KarMMa-3 study’s findings with overall survival as a key secondary endpoint.

The FDA will consider this recommendation during its review of the supplemental biologics license application (sBLA) for Abecma. While the FDA has not set a new target action date for the sBLA review, the ODAC’s positive vote was swayed by interim overall survival data from the KarMMa-3 study.

Abecma has recently gained approval in Japan and Switzerland for patients with relapsed and/or refractory multiple myeloma who have received a minimum of two therapies previously. These treatments include an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

Additionally, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recently provided a positive opinion on expanding Abecma’s indication.

Multiple Myeloma

A CAR-T Therapy Poised to Transform Multiple Myeloma Care, Endorsed by ODAC

Anne Kerber, Bristol Myers Squibb Hematology, Oncology, and Cell Therapy Late Clinical Development head and senior vice-president, expressed satisfaction with the ODAC meeting’s positive outcome. She highlighted the favorable benefit/risk profile of Abecma and confidence in the significant clinical benefit that Abecma offers for patients with triple-class exposed relapsed or refractory multiple myeloma.

Kerber emphasized the absence of a clear effective standard of care in earlier lines of therapy for this incurable disease, and the potential of Abecma as a transformative therapy for more patients in need. She also expressed anticipation for the FDA’s completion of the sBLA review.

In essence, Abecma, a CAR-T cell immunotherapy, has received a positive recommendation from the ODAC. This recommendation, based on the KarMMa-3 study’s findings, supports the therapy’s favorable benefit/risk profile. Abecma has already gained approval in Japan and Switzerland and a positive opinion from the CHMP of the EMA for expanded indication. The therapy offers a promising treatment option for patients with relapsed or refractory multiple myeloma, a disease currently lacking a clear standard of care in earlier therapy lines.

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