BMS announced positive topline results from two studies, TRANSCEND FL for R/R Follicular Lymphoma (FL) and TRANSCEND NHL 001, a Phase 1 pivotal study for mantle cell lymphoma (MCL)

Results demonstrated, both studies met the primary endpoint of overall response rate, with Breyanzi demonstrating statistically significant and clinically meaningful responses in R/R FL and MCL

The studies also met the key secondary endpoint of complete response rate, demonstrating high rates of complete responses in both relapsed or refractory FL and MCL

No new safety signals were reported for Breyanzi in either of these studies

“This approval represents a significant milestone for patients with continued progress toward transforming second-line treatment practice to provide a personalized treatment option that offers the potential for durable remission,” said Bertram Glass, M.D., TRANSFORM trial investigator and Chief Physician of the Department of Hematology and Stem Cell Transplantation, Helios Klinikum, Berlin, Germany