New indication approved for Gazyva in Japan

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva (obinutuzumab [genetical recombination]) intravenous infusion for an additional indication of CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma).

The drug was first launched in Japan by Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Roche (ROG: SIX), with partner Nippon Shinyaku (TYO: 4516) in August 2018, as a treatment for follicular lymphoma.

“We are very pleased that this line extension enables us to offer the combination treatment as a new treatment option for patients with chronic lymphocytic leukemia (CLL),” said Chugai’s president and chief executive Dr Osamu Okuda, adding: “CLL has a long disease course. We will continue to provide information on efficacy and safety of Gazyva for the benefit of patients with CLL.”