Japan approves Bristol Myers Squibb’s B-cell lymphoma therapy

Bristol Myers Squibb has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for its Breyanzi (lisocabtagene maraleucel; liso-cel) to treat patients suffering from relapsed or refractory (R/R) large B-cell lymphoma (LBCL) and R/R follicular lymphoma.

Breyanzi is a new CD19-directed chimeric antigen receptor (CAR) T cell therapy.

The LBCL includes diffuse large B-cell lymphoma (DLBCL), which is common form of non-Hodgkin lymphoma in Japan.

Bristol Myers Squibb noted that there is no established standard-of-care treatment available for patients suffering with R/R large B-cell lymphoma.

The company will manufacture the new CAR T cell therapy at its cellular immunotherapy facility located in Bothell, Washington as well as at a partner company facility in Japan.

Bristol-Myers Squibb K.K. and Celgene K.K. president and CEO Jean-Christophe Barland said: “I am pleased that we have received regulatory approval in Japan for Breyanzi, our first CAR T cell therapy, which will allow us to provide a new treatment option for patients fighting relapsed or refractory large B-cell lymphoma and relapsed or refractory follicular lymphoma.

“In addition, we are filing an application for a further CAR T cell therapy to address more unmet medical needs. As a game-changer committed to ‘innovation with heart’, Bristol Myers Squibb will continue on its journey to help patients prevail over serious diseases.”

The MHLW approval is based on efficacy and safety of the TRANSCEND NHL 001 trial conducted on 269 patients with R/R B-cell non-Hodgkin lymphoma (NHL).

It is also based on the results of TRANSCEND WORLD trial conducted on 34 patients with R/R aggressive B-cell NHL who received Breyanzi.

The latest move follows the receipt of US Food and Drug Administration (USFDA) approval for Breyanzi last month.