Bristol-Myers Squibb Co. recently publicized that the FDA has approved the submission of two supplementary Biologics License Applications (sBLA) for their drug Breyanzi. This comes for the treatment of two conditions, recurrent or refractory follicular lymphoma (FL) and recurrent or refractory mantle cell lymphoma (MCL). Similarly, Japan's Ministry of Health, Labour, and Welfare has authorized the sNDA for Breyanzi for the treatment of recurrent or refractory FL. The FDA has conferred Priority Review status on both applications and has set target dates for Breyanzi's evaluations, specifically May 23, 2024, for recurrent or refractory FL, and May 31, 2024, for recurrent or refractory MCL.
The basis for the applications for Breyanzi in the US and Japan arises from results derived from the TRANSCEND FL study for recurrent or refractory FL. As far as recurrent or refractory MCL is concerned, the US application is predicated on outcomes from the MCL cohort of the TRANSCEND NHL 001 study.
In both studies, Breyanzi was noted to maintain a consistent safety record with no new safety issues surfacing.
Bristol-Myers Squibb Co. added that an sBLA for Breyanzi for the treatment of adult patients having recurrent or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, who have undergone prior treatments involving BTKi and B-cell lymphoma 2 inhibitors, is presently under Priority Review. The FDA has set a target action date of March 14, 2024, for this particular application.
