Japan’s MHLW approves Breyanzi, a new CAR T cell therapy for the treatment of patients with relapsed or refractory large B-cell lymphoma and follicular lymphoma.- BMS KK

Bristol Myers Squibb K.K. announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) 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. 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,3 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. ent for patients with follicular lymphoma graThere is also no established standard-of-care treatmde 3B.