Shots:
The approval was based on the P-III (TRANSFORM) study evaluating Breyanzi vs standard therapy regimens in adults with LBCL that was primary refractory or relapsed within 12mos. after 1L therapy
The results showed improvements in EFS, CR & PFS; m-EFS (10.1mos. vs 2.3mos.); CR (66% vs 39%) with a median duration of CR (not reached); m-PFS (14.8mos. vs 5.7mos.), 97% received treatment over 47% who completed high-dose CT & autologous HSCT, well-established safety profile
The approval was also based on the P-II (PILOT) study which showed deep & durable responses with ORR (80%), CR rate (54%) with a median time to CR of 1mos., m-DoR (11.2mos.) while m-DoR was not reached in those patients who achieved a CR
Ref: Globenewswire| Image: BMS
