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BMS' Breyanzi was approved for relapsed or refractory LBCL | News | FDA | iPharmacenter

Updated: Jun 26, 2023

Bristol Myers Squibb announced that Breyanzi (lisocabtagene maraleucel) was approved by the U.S. Food and Drug Administration (FDA) for treating adult patients with refractory or relapsed patients with large B-cell lymphoma (LBCL). Breyanzi is approved for diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma.

The approval was based on the Phase 3 TRANSFORM trial and Phase 2 PILOT study. In the Phase 3 TRANSFORM trial, adult patients with LBCL were relapsed or refractory within 12 months of front-line therapy. They were randomized to either Breyanzi or standard of care (including salvage chemotherapy and high-dose chemotherapy or HSCT if patients have responses). The event-free survival was four times higher than the standard of care (10.1 months vs. 2.3 months). 66% of patients achieved complete response versus 39% on standard of care. The progression-free survival was 14.8 months versus 5.7 months in patients on standard of care.

In the Phase 2 PILOT study, patients who were not the candidates for stem cell transplant were included. Breyanzi demonstrated an overall response of 80% and a complete response of 54%.

BMS announced that Breyanzi had a well-established safety profile; grade 3 CRS was reported in only 1.3% of patients.

With this approval, BMS announced that Breyanzi has the widest population for CAR T therapy in patients with LBCL. Further, Breyanzi was not approved for primary central nervous system lymphoma.

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