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Drugmaker will fight FDA decision to restrict breast cancer therapy

chemo pic.jpgSwiss pharmaceutical giant Roche intends to challenge the US Food and Drug Administration (FDA) over its decision to revoke approval of the drug Avastin (bevacizumab)for the treatment of advanced breast cancer.

US regulators announced yesterday that the drug’s marginal benefits for breast cancer patients failed to outweigh its risks, which include internal bleeding and high blood pressure. Avastin will retain its other indications, including colorectal cancer and lung cancer, and will be available to breast cancer patients if physicians choose to prescribe it off-label. Such prescriptions, however, are rarely reimbursed by health insurance companies: a major concern for a drug that can cost $88,000 per year (Newsday).

Genentech, the California-based division of Roche that developed Avastin, countered that it will ask for an additional public hearing on the matter. To bolster its argument that Avastin should remain available to breast cancer patients, the company pointed to the European Medicines Agency, which yesterday announced that it had determined the drug did provide modest benefits against breast cancer when combined with the chemotherapy paclitaxel.

According to the Washington Post, Roche will be the first company to exercise the option to challenge an FDA decision of this nature.


Avastin, which targets blood vessels, had once been hailed as the future of cancer therapy, but its performance in the clinic has been disappointing. Fierce Pharma notes that Genentech has been searching for biological markers that could identify ‘super-responders’, those rare patients who dramatically improve on Avastin. The search has yet to bear fruit.

Photo: IndyDina and Mr. Wonderful via Flickr

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