BMY - Bristol Myers' Breyanzi Scores Second FDA Approval For Blood Cancers Therapy | Benzinga
The FDA granted accelerated approval on Thursday to Bristol Myers Squibb Co.’s (NYSE:BMY) of Breyanzi (lisocabtagene maraleucel, liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
The approval covers patients who have received at least two prior lines of therapy.
In June 2022, the FDA approved Breyanzi for adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma.
This expanded indication is approved under accelerated approval based on response rate and duration of response.
Continued approval for this indication may be contingent ...