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Four PDUFA dates coming in May


BMS awaits decisions on two new indications for Breyanzi; therapies from Ascendis, Dynavax also up for approvals

By Gunjan Ohri, Data Content Analyst

May 2, 2024 12:29 AM UTC

FDA has set target action dates in May for at least four applications, two of which are seeking new indications for BMS’s CAR T therapy Breyanzi.

Since its first approval in 2021 for third-line large B cell lymphoma, CD19 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 (CLL) and small lymphocytic lymphoma (SLL) following use of Btk and BCL2 inhibitors…