Bristol Myers Squibb has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for its Breyanzi (lisocabtagene maraleucel: liso-cel) to treat a type of lymphoma.
The Japanese regulator indicated Breyanzi for the treatment of relapsed or refractory (R/R) large B-cell lymphoma and R/R follicular lymphoma.
Breyanzi is a chimeric antigen receptor (CAR) T cell therapy, designed to target CD19, a biomarker for normal B cells, and involved in establishing B cell signalling.
The drug works by targeting CD19-expressing cells and is administered in a one-time infusion to minimise the variability of the CD8 and CD4 component dose.
The biopharmaceutical firm intends to manufacture Breyanzi at its cellular immunotherapy manufacturing facility in Bothell, Washington and at a partner company facility in Japan.
Bristol-Myers Squibb and Celgene 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 Japanese regulatory approval is based on efficacy and safety from the TRANSCEND NHL 001 and the TRANSCEND WORLD trials.
The TRANSCEND NHL 001 trial evaluated the drug in 269 patients with R/R B-cell non-Hodgkin lymphoma (NHL) and met the primary endpoint of 74.4% overall response rate.
Also, treatment using anti-CD19 CAR T cells in the efficacy analysis population of 256 subjects demonstrated an overall response rate of 72.7%.
The TRANSCEND WORLD trial evaluated the drug in 34 patients with R/R aggressive B-cell NHL and has met the primary endpoint of 58.8%, exceeding the threshold value of 40%.
Breyanzi was previously approved in the US for treating relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
Furthermore, the drug has been granted Priority Medicines (PRIME) designation for relapsed or refractory DLBCL in the European Union, with a Marketing Authorisation application under review by the European Medicines Agency.
