Shots:

• The approval is based on the P-II (BB2121-MM-001) study & the P-I (CRB-401) dose-expansion & escalation cohort to evaluate Abecma in 149 & 67 patients with r/r MM who have received 3 prior therapies including an immunomodulatory agent, a proteasome inhibitor & anti-CD38 Ab
• In the P-II trial, the therapy showed ORR (73.4%) in 128 non-Japanese patients at a target dose of 150, 300, or 450 x 106 & ORR (88.9%) in 9 Japanese patients at the target dose of 450 x 106. In the P-I trial, ORR (74.2%) in the 62 patients & 84.2% in the 38 patients (target dose of 450 x 106)
• Abecma is a BCMA-directed CAR T cell immunotherapy & 1st CAR T cell therapy approved for r/r MM in Japan

Ref: BMS | Image: BMS