Posted by Michael Wonder on 28 Mar 2022
Japan's Ministry of Health, Labour and Welfare accepts Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma
25 March 2022 - Bristol-Myers Squibb today announced that the 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 large B-cell lymphoma.
This is the first CAR T cell therapy application filed for the second-line treatment of relapsed or refractory large B-cell lymphoma in Japan.
The acceptance is based on the efficacy and safety data yielded by the TRANSFORM study in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma conducted in Japan, the U.S. and the EU, and other studies.
