NDA filed for immune checkpoint inhibitor, atezolizumab, in Japan

Japan’s Chugai Pharmaceutical (TYO: 4519) has filed a new drug application to the Ministry of Health, Labor and Welfare (MHLW), for engineered anti PD-L1 monoclonal antibody atezolizumab (genetic recombinant) for the treatment of unresectable advanced or recurrent non-small cell lung cancer (NSCLC).

“The cancer immunotherapy has set a new trend of cancer treatment worldwide,” said Dr Yasushi Ito, Chugai’s senior vice president, head of Project & Lifecycle Management Unit. ”Atezolizumab, an immune checkpoint inhibitor, is the only anti PD-L1 antibody approved in the United States for the treatment of lung cancer. We are committed to deliver atezolizumab to patients as early as possible to contribute to the development of and access to better treatments in Japan,” Dr Ito added.

Chugai, which is majority-owned by Swiss pharma giant Roche (ROG: SIX), filed the application with the MHLW based on the results from a global Phase III clinical study (the OAK study) and several clinical studies. Atezolizumab, overseas brand name Tecentriq, was approved in the USA for the treatment of locally advanced or metastatic urothelial carcinoma (UC) in May, 2016, and for the treatment of metastatic NSCLC patients who have disease progression during or following platinum-containing chemotherapy in October, 2016.