Chugai pushed into filing for Avastin glioblastoma indication in Japan

Japanese drugmaker Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Swiss drug major Roche (ROG: SIX), says that it has filed an application with the Japanese Ministry of Health, Labor and Welfare (MHLW) for the approval of an additional indication of recurrent glioblastoma for the anti-cancer agent/ anti-VEGF humanized monoclonal antibody Avastin (bevacizumab) IV Infusion 100mg/4mL and 400mg/16mL.

Avastin, a blockbuster drug for Roche in several cancer indications, is currently approved in the USA and over 30 countries worldwide for the treatment of glioblastoma as a single agent and in some countries in combination with irinotecan for adult patients with progressive disease following prior therapy (relapsed setting).

On April 6, Chugai received a request from the MHLW to develop Avastin for the treatment of recurrent glioblastoma, as a result of the evaluation by the 11th Review Committee on Unapproved Drugs and Indications with High Medical Needs held on March 23, 2012, and has been preparing to file for the addition of this indication. On September 13, Avastin for glioblastoma was designated as orphan drug, as the estimated number of newly diagnosed glioblastoma patient per year is about 1,000.