NEW YORK CITY (dpa-AFX) - Bristol Myers Squibb (BMY) and 2seventy bio, Inc. (TSVT) announced the FDA Oncologic Drugs Advisory Committee will meet to review data supporting the supplemental Biologics License Application for Abecma for earlier lines of triple-class exposed relapsed or refractory multiple myeloma based on results from the Phase 3 KarMMa-3 study. The date of the ODAC meeting has not yet been confirmed by the FDA. The FDA also informed that a decision on the application will not be made by the PDUFA target action date of December 16, 2023.
The companies stated that the ODAC meeting has no impact on the currently approved indication for Abecma. Regulatory applications for Abecma are also currently under review by Japan's Ministry of Health, Labour and Welfare, European Medicines Agency and Swissmedic.
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