Bristol Myers, 2seventy Bio provide update on FDA review of Abecma application

Bristol Myers (BMY) and 2seventy bio (TSVT) announced the FDA Oncologic Drugs Advisory Committee – ODAC – will meet to review data supporting the supplemental Biologics License Application – sBLA – for Abecma for earlier lines of triple-class exposed relapsed or refractory multiple myeloma – RRMM – based on results from the pivotal Phase 3 KarMMa-3 study. The date of the ODAC meeting has not yet been confirmed by the FDA. The FDA also informed the companies that a decision on the application will not be made by the Prescription Drug User Fee Act target action date of December 16. The companies anticipate that the committee will review data related to the secondary endpoint of overall survival. The KarMMa-3 study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival vs. standard regimens. Regulatory applications for Abecma in earlier lines of therapy for triple-class exposed RRMM based on the KarMMa-3 study results are also currently under review by Japan’s Ministry of Health, Labour and Welfare, European Medicines Agency and Swissmedic.