Bristol Myers Squibb and 2seventy bio Share Update on U.S. FDA Oncologic Drugs Advisory Committee Meeting for Abecma in Triple-Class Exposed Multiple Myeloma Based on KarMMa-3 Study
The companies anticipate that the ODAC will review data related to the secondary endpoint of overall survival (OS) from the study.
- The companies anticipate that the ODAC will review data related to the secondary endpoint of overall survival (OS) from the study.
- Final PFS data and interim OS data from the KarMMa-3 study were presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition in December 2023.
- Abecma also received a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for patients with triple-class exposed relapsed and refractory multiple myeloma after at least two prior therapies.
- Regulatory applications for Abecma for this patient population remain under review with the EMA and Swissmedic.