By Michael Dabaie
Bristol Myers Squibb and bluebird bio Inc. said they submitted their biologics license application to the U.S. Food and Drug Administration for idecabtagene vicleucel.
Idecabtagene vicleucel is the companies' lead investigational immunotherapy for the treatment of adult patients with multiple myeloma who have received at least three prior therapies.
The submission is based on results from the pivotal Phase 2 KarMMa study. Topline data from the study, reported in December, indicated the study met its primary endpoint of overall response rate, and the key secondary endpoint of complete response rate.
Write to Michael Dabaie at firstname.lastname@example.org