Bristol-Myers Says Regulatory Applications For Breyanzi Accepted By FDA, Japan's MHLW

(RTTNews) - Bristol-Myers Squibb Co. (BMY) announced Tuesday that the FDA has accepted two supplemental Biologics License Applications or sBLA for Breyanzi for the treatment of relapsed or refractory follicular lymphoma or FL and relapsed or refractory mantle cell lymphoma or MCL. Japan's Ministry of Health, Labour, and Welfare or MHLW has also accepted the sNDA for Breyanzi for the treatment of relapsed or refractory FL. Both applications have been granted Priority Review by the FDA, and the agency has assigned a Prescription Drug User Fee Act goal date of May 23, 2024, for Breyanzi in relapsed or refractory FL and May 31, 2024, for Breyanzi in relapsed or refractory MCL.

In the case of relapsed or refractory FL, the applications for Breyanzi in the U.S. and Japan are based on results from the TRANSCEND FL study. Regarding relapsed or refractory MCL, the application for Breyanzi in the U.S. is based on results from the MCL cohort of the TRANSCEND NHL 001 study.

In both studies, Breyanzi demonstrated a consistent safety profile with no new safety signals reported.

The company also stated that a sBLA for Breyanzi for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received a prior BTKi and B-cell lymphoma 2 inhibitor is also currently under Priority Review with the FDA with an assigned target action date of March 14, 2024.