Filing for additional Gazyva indication of CLL in Japan

Japanese drug major Chugai Pharmaceutical (TYO: 4519) Chugai has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW), for approval of an anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva (obinutuzumab), intravenous infusion 1000mg (genetical recombination)] for the treatment of chronic lymphocytic leukemia (CLL).

The drug was first launched by Chugai, which is majority-owned by Roche (ROG: SIX), with partner Nippon Shinyaku (TYO; 4516) in August 2018.

“Ensuring safety during long-term treatment is increasingly important as the recent expansion in treatment options may lead to longer survival for patients with CLL. As a result, there is a growing unmet medical need for treatments that control disease and have an acceptable safety profile,” said Chugai’s president and chief executive, Dr Osamu Okuda. “We are working towards approval of Gazyva so the drug can contribute to treatment as a new therapeutic option for CLL,” he noted.