The US Food and Drug Administration will hold an Oncologic Drugs Advisory Committee (ODAC) meeting to review Bristol Myers Squibb Company and 2seventy Bio, Inc.’s supplemental biologics license application (sBLA) for the CAR-T therapy Abecma (idecabtagene vicleucel) for earlier lines of multiple myeloma, meaning it will miss the the 16 December FDA action date.
Key Takeaways
- The FDA plans to convene an advisory committee to review approval of Abecma in earlier lines of multiple myeloma therapy, and will miss the original user fee deadline.
- Bristol and 2seventy bio have hoped a lead in earlier lines of therapy would give Abecma an edge over J&J’s Carvykti
The companies announced the update on 20 November and said an advisory committee meeting date has not been set. The companies expect the ODAC panel will review overall survival data from the KarMMa-3 study in patients after two to four prior therapies, the basis of the application. The Phase III trial met the primary endpoint of progression-free survival, showing a 51% reduction in risk of disease progression or death with Abecma versus standard regimens
