FDA label expansions in May: Two new indications for BMS’s CAR T

Among the handful of label expansions granted last month by FDA’s Center for Drug Evaluation and Research was a pair of new indications for CAR T cell therapy Breyanzi.

Since its first approval in 2021 for third-line large B cell lymphoma, CD19-directed CAR T therapy Breyanzi lisocabtagene maraleucel from  Bristol Myers Squibb Co. (NYSE:BMY) has advanced into second-line LBCL, and in March, was granted accelerated approval to treat chronic lymphocytic leukemia and small lymphocytic lymphoma following use of Btk and BCL2 inhibitors...