FDA approves Breyanzi (lisocabtagene maraleucel; liso-cel) as a new CAR T cell therapy for relapsed or refractory Mantle Cell lymphoma.- BMS

This FDA approval marks the fourth distinct subtype of non-Hodgkin lymphoma for which Breyanzi is approved, making it the CAR T cell therapy available to treat the broadest array of B-cell malignancies. In relapsed or refractory MCL, Breyanzi is delivered as a one-time infusion* with a single dose containing 90 to 110 x 106 CAR-positive viable T cells.

MCL is a rare but aggressive form of non-Hodgkin lymphoma, and many patients relapse or become resistant to frontline therapies. Currently, MCL is considered an incurable disease, and response rates and duration of response tend to decrease with each additional relapse..

" There have been few advances in the treatment of relapsed or refractory MCL, and prognosis worsens for patients after each subsequent relapse, often leaving them with high disease burden and difficulty achieving deep and durable responses,” said Michael Wang, M.D., lead investigator and Puddin Clarke Endowed Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas. “The approval of Breyanzi offers an important new CAR T treatment option with high rates of lasting responses and a consistent safety profile, which is critically important for these patients who currently have limited options to treat this aggressive disease.”