MHLW (Japan) accepts sNDA for Breyanzi to treat large B-cell lymphoma.
Bristol-Myers Squibb K.K. 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, and is especially prevalent among those in their 60s. 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.
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