Chugai/Roche file Avastin in Japan
Swiss drug major Roche says that its Japanese subsidiary, Chugai, has submitted a New Drug Application with the Ministry of Health, Labor and Welfare for the use of its Avastin (bevacizumab) in patients with advanced or recurrent colorectal cancer.
The product has been filed under a new "fast regulatory" scheme that has been established by the Investigational Committee for Usage of Unapproved Drugs (a body established by the MHLW).
The system, Roche explains, has been set up to enable faster regulatory approval of certain medicines with proven efficacy which are approved in the USA and/or Europe but that are not yet available in Japan. Avastin is the first medicine to be filed under this scheme for an indication as significant as colorectal cancer, the firm notes.
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