epocrates
CAR-T cell therapy earns expanded indications
Breyanzi was initially approved in the U.S. in June 2022 to treat large B-cell lymphoma in adults whose disease has returned or stopped responding to treatment. (Satija, 2024)
In the phase 1/2 TRANSCEND CLL 004 study, the first pivotal multicenter trial to evaluate a CAR-T cell therapy in patients with relapsed or refractory CLL or SLL, the complete response rate associated with Breyanzi treatment was 20% (95% CI, 11.1-31.8). (Business Wire, 2024)
Breyanzi is delivered through a process which culminates in a one-time infusion with a single dose containing 90 to 110 x 10^6 CAR-positive viable T cells.
Sources:
Satija, B. et al. (2024, March 14). Reuters. U.S. FDA expands use of Bristol Myers' cancer therapy. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-expands-use-bristol-myers-cancer-therapy-2024-03-15/
(2024, March 14). Business Wire. U.S. FDA Approves Bristol Myers Squibb’s Breyanzi as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). https://www.businesswire.com/news/home/20240313169337/en/U.S.-FDA-Approves-Bristol-Myers-Squibb%E2%80%99s-Breyanzi%C2%AE-as-the-First-and-Only-CAR-T-Cell-Therapy-for-Adults-with-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-CLL-or-Small-Lymphocytic-Lymphoma-SLL