Bristol-Myers Squibb announced that the Ministry of Health, Labour and Welfare (MHLW) has accepted the supplemental New Drug Application for Breyanzi (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the second-line treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). This is the first CAR T cell therapy application filed for the second-line treatment of R/R LBCL in Japan.

The acceptance is based on the efficacy and safety data yielded by the TRANSFORM study in patients with R/R aggressive B-cell non-Hodgkin lymphoma conducted in Japan, the U.S. and the EU, and other studies.

LBCL 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,1 and is especially prevalent among those in their 60s.2 There are currently no established standard-of-care treatment options for patients with R/R LBCL,3 which underscores the need for new treatments for this disease.

Makoto Sugita, Vice President, R&D Japan, Bristol-Myers Squibb K.K., commented, "I am pleased we are the first company in Japan to file an application for a cell therapy in second-line relapsed or refractory large B-cell lymphoma. This filing brings us one step closer to delivering a potentially practice-changing treatment for primary relapsed or refractory large B-cell lymphoma, making Breyanzi available to more patients in need, and underscores the advancements we’re making in cell therapy research to transform the lives of patients with difficult-to-treat blood cancers, including lymphoma.”

Breyanzi is a CD19-directed CAR T cell therapy with a defined composition and 4-1BB costimulatory domain. Breyanzi is administered as a defined composition to reduce variability of the CD8 and CD4 component dose. The 4-1BB signaling domain enhances the expansion and persistence of the CAR T cells. Breyanzi has been designated as an orphan regenerative medicine product by the MHLW for aggressive B-cell non-Hodgkin lymphoma, and was approved in March 2021 for the treatment of patients with R/R LBCL and R/R follicular lymphoma.