NDA filing for obinutuzumab in Japan

Japanese drug major Chugai Pharmaceutical (TYO: 4529) has filed a new drug application to the Ministry of Health, Labor and Welfare (MHLW), for glycoengineered type II anti-CD20 monoclonal antibody, obinutuzumab (genetical recombination) which was co-developed with Nippon Shinyaku (TYO: 4526) for the treatment of “CD20-positive B-cell follicular lymphoma (FL) in Japan.

Under the trade names Gazyvaro and Gazyva, obinutuzumab is already approved and marketed in Europe, the USA and elsewhere by Swiss pharma giant Roche (ROG: SIX), which has a majority stake of Chugai. The drug generated sales of 133 million Swiss francs ($138 million) in the first six months of 2017.

This filing was based on the results of the GALLIUM study, a global Phase III clinical study conducted by Roche and participating from Japan and other several clinical studies.
The GALLIUM study is a global Phase III open-label, multi-center, randomized two-arm study that evaluated the efficacy and safety of obinutuzumab plus chemotherapy followed by obinutuzumab alone (obinutuzumab arm) compared with rituximab plus chemotherapy followed by rituximab alone (rituximab arm) in 1,401 patients with previously untreated CD20-positive advanced non-Hodgkin’s lymphoma. The primary endpoint of the study was investigator-assessed progression free survival (PFS) in 1,202 patients with FL. The secondary endpoints were PFS assessed by an independent review committee (IRC), overall survival (OS), safety, and other endpoints.