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European advisory committee declines to recommend Avastin approval for deadly brain cancer


Posted on: 11/21/2009

European advisory committee declines to recommend Avastin approval for deadly brain cancer

By Alaric DeArment

BASEL, Switzerland (Nov. 20) A medical advisory committee in Europe has declined to recommend approval for a Roche drug as a treatment for a deadly form of brain cancer, Roche announced Friday.

The Swiss drug maker said the Committee for Medicinal Products for Human Use, which is responsible for initial assessment of drugs filed for regulatory approval in Europe, did not recommend approval for the drug Avastin (bevacizumab) alone or combined with the chemotherapy drug irinotecan for treating relapsed or progressive glioblastoma. Glioblastoma, or GBM, is the most aggressive type of primary malignant brain cancer.

The committee, which made its decision based on results of a mid-stage clinical trial that Roche had submitted, cited the lack of a comparator arm that included patients who did not take Avastin.

“We are very disappointed with the CHMP opinion, which will result in a delay to patients receiving an important new treatment option,” Roche Pharmaceuticals Division CEO William Burns said in a statement. “We strongly believe that Avastin is a new treatment option for physicians within the [European Union] which would bring hope to GBM patients and their families as it is today in the U.S. and other countries.”


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