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news.Chugai, a member of the Roche Group has reported that marketing approval has been granted for use of the cancer drug Avastin in patients with inoperable colorectal cancer in Japan.
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The Japanese Ministry of Health, Labor and Welfare has granted this approval following a recommendation, made in July 2005 by the Investigational Committee for Usage of Unapproved Drugs, that an early filing be made for Avastin. This process enables faster submission of certain medicines with proven efficacy which are approved in the US and Europe but are not yet available in Japan.
This approval is based on Japanese phase I and safety confirmation study data, along with supporting US and European phase II and phase III data which demonstrated Avastin’s improvement of overall and progression-free survival in metastatic colorectal cancer.
According to Roche, Avastin is the first and only anti-angiogenic agent which has been shown to consistently deliver an improved survival benefit for colorectal, lung, breast and renal cell cancer patients.