FDA Grants Priority Review to BMS’ Supplemental BLA for Breyanzi

The FDA has granted a Priority Review to Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) as a second-line treatment for adults with relapsed or refractory B-cell lymphoma.

The supplemental Biologics License Application (sBLA) was supported by phase 3 results showing Breyanzi significantly improved event-free survival when compared to the standard-of-care treatment known as salvage chemotherapy.

The FDA has set a Prescription Drug User Fee Act-mandated target decision date of June 24.

Breyanzi, a chimeric antigen receptor T-cell drug, is currently approved for patients with certain types of large B-cell lymphoma who have failed at least two other types of systemic treatment.

February 18, 2022

https://www.fdanews.com/