The FDA has granted accelerated approval to Bristol Myers Squibb's Breyanzi, a CAR T-cell therapy indicated for types of lymphoma and leukemia.
Breyanzi (lisocabtagene maraleucel) is now approved for adults with relapsed or refractory follicular lymphoma who have received at least two other systemic therapies, according to a May 15 news release from BMS.
In a clinical trial of 101 patients, 94% of study participants achieved a complete response and 97% showed an overall response rate.
The one-time infusion therapy is also approved for relapsed or refractory large B-cell lymphoma, relapsed or refractory chronic lymphocytic leukemia, and small lymphocytic lymphoma.