Genentech attempts to keep Avastin's breast cancer indication

08/7/2011 | Genetic Engineering & Biotechnology News

In a post-hearing document, Genentech asked the FDA to retain Avastin's breast cancer approval by allowing an updated label as well as a risk evaluation and mitigation strategy and a medication guide. The company also reiterated its plan to undertake a confirmatory study of Avastin plus chemotherapy drug paclitaxel for HER2-negative metastatic breast cancer.

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