Japan's MHLW approves a new CAR-T cell therapy, Breyanzi

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Breyanzi (lisocabtagene maraleucel: liso-cel), a CD19-directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma and R/R follicular lymphoma, from US pharma major Bristol Myers Squibb (NYSE: BMY).

The approval is based on efficacy and safety from the TRANSCEND NHL 001 trial in patients with R/R B-cell non-Hodgkin lymphoma (NHL) and the TRANSCEND WORLD trial in patients with R/R aggressive B-cell NHL.

Large B-cell lymphoma comprises several disease types including diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common form of non-Hodgkin lymphoma in Japan, accounting for 30%-40% of all B-cell cases diagnosed, and is especially prevalent among people in their 60’s. There is currently no established standard-of-care treatment for patients with R/R large B-cell lymphoma, which underscores the need for new treatments for in this disease area. Follicular lymphoma accounts for 10%-20% of all B-cell NHL cases in Japan. Patients initially respond to chemotherapy, but relapse is common, especially in advanced-stage patients. There is also no established standard-of-care treatment for patients with follicular lymphoma grade 3B.