Multiple Myeloma Drug Gains Priority Review
The FDA has granted a priority review to a biologics license application (BLA) for idecabtagene vicleucel (ide-cel) for adults with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Submitted by Bristol Myers Squibb and Bluebird Bio, the BLA is supported by results from a phase 2 clinical trial of three different doses in 128 patients. Ide-cell demonstrated a 73 percent overall response rate across all three dosage levels with median progression-free survival lasting 8.6 months.
The FDA is expected to issue a decision on the application by March 27, 2021.