ODAC

The US Food and Drug Administration's Oncologic Drugs Advisory Committee has voted five to four against approving the anticancer agent Avastin (bevacizumab) for breast cancer. The Committee said that the drug, which was co-developed by USA-based biotechnology major Genentech and its Swiss majority-owner Roche, had failed to show a positive risk/benefit profile when combined with paclitaxel in women with recurrent or metastatic HER2-negative breast cancer who were yet to receive chemotherapy.

Natalie Portis, a patient representative on the committee, told the New York Times that "it's a very painful reality that metastatic breast cancer is not curable...I don't think that this means we should just say 'well, here, try this' if there isn't meaningful data to support it."

In response, Genentech said: "we are disappointed by the split vote of the advisory committee, as the addition of Avastin to chemotherapy showed the longest reported progression-free survival in any first-line clinical trial of patients with advanced breast cancer [Marketletter September 18, 2006]." The Maryland-headquartered firm also said that it believes progression-free survival is a meaningful endpoint.