Roche’s Japanese subsidiary Chugai Pharmaceutical filed cancer drug Avastin for fast-track approval with the Japanese regulatory authority.
Chugai has filed for approval for the use of Avastin (bevacizumab), in patients with advanced or recurrent colorectal cancer, under Japan’s recently implemented priority review scheme, set up by the Investigational Committee for Usage of Unapproved Drugs.
The system has been set up to enable faster regulatory approval of certain medicines with proven efficacy which are approved in the US and/or Europe but that are not yet available in Japan. Avastin is the first medicine to be filed under the scheme.
Avastin is already approved in the USA and Europe for colorectal cancer, and pulled in sales of 1.7 billion Swiss francs ($1.3 billion) for Roche in 2005 - its first full year on the market.
Earlier this month Roche and its partner for the drug, Genentech, filed in the USA for approval to extend the indications for the drug to include non-small cell lung cancer, and intends shortly to also submit a dossier for the drug in breast cancer.