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news.The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted in favour of Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma (idecabtagene vicleucel) for treating triple-class exposed relapsed or refractory multiple myeloma.
BMS and 2seventy bio have submitted supplemental biologics license application seeking approval for Abecma. Credit: Bristol-Myers Squibb Company.
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Abecma is a B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR)-T cell immunotherapy.
The ODAC validated the favourable benefit/risk profile of the therapy based on findings from the Phase III KarMMa-3 study with overall survival as key secondary endpoint.
Its recommendation will be taken into account by the FDA during its review of the supplemental biologics license application (sBLA) for Abecma.
Although the FDA has not set a new target action date for the sBLA review, the ODAC’s positive vote was influenced by interim overall survival data from the KarMMa-3 study.
Recently, Abecma received approval in Japan and Switzerland for patients with relapsed and/or refractory multiple myeloma who have received a minimum of two therapies previously.
These therapies comprise an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
Furthermore, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently issued a positive opinion on expanding Abecma’s indication.
Bristol Myers Squibb Hematology, Oncology and Cell Therapy Late Clinical Development head and senior vice-president Anne Kerber said: “We are extremely pleased with the positive outcome of the ODAC meeting, which recognises the favourable 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.
“We look forward to working with the FDA as it completes review of our sBLA in order to bring this potentially transformative therapy to more patients in need.”