- The approval is based on pivotal TRANSCEND NHL 001 (017001) study assessing Breyanzi in 268 patients with 3L+R/R LBCL including patients with a broad range of histologies and high-risk disease. Breyanzi was administered in the inpatient & outpatient settings
- Results: ORR (73%); CR (54%); PR (19%); mDOR (16.7mos.) in all responders; patients with best response or PR, mDOR (1.4mos.); patients achieving CR, 65% had remission lasting at least 6mos. and 62% had remission lasting at least 9mos.
- Breyanzi is a CD19-directed CAR T cell therapy with defined composition and 4-1BB costimulatory domain. Additionally, the US FDA has granted ODD, RMAT and BT Designation to the therapy