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news.Genentech, a member of the Roche Group, has stated that the Oncologic Drugs Advisory Committee (ODAC) of FDA has voted 12 to one that use of Avastin (bevacizumab) in combination with paclitaxel for previously untreated (first-line) advanced HER2-negative breast cancer be removed from Avastin's US label.
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Genentech said that the committee’s vote has no effect on the present availability of Avastin for people with advanced HER2-negative breast cancer in the US.
The decision on the first-line use of Avastin in combination with certain types of chemotherapy in the US for advanced breast cancer will be made by FDA on September 17, 2010.
Avastin, in combination with paclitaxel chemotherapy, is currently approved as a first-line treatment of advanced HER2-negative breast cancer.
Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease.
Genentech has submitted, to the FDA, two supplemental biologics license applications (sBLAs), based on the Avado and Ribbon 1 studies as part of the company’s effort to convert the accelerated approval to a full approval.
The ODAC reviewed data from all three studies (E2100, Avado and Ribbon 1), which showed that Avastin plus commonly used chemotherapies (taxane-based, anthracycline-based or capecitabine chemotherapy) increased the time women lived without the disease growing or spreading (PFS), compared to the chemotherapies alone.
Sandra Horning, senior vice president and global head of clinical development hematology/oncology at Genentech, said: “We are disappointed by the committee’s recommendation and believe Avastin should continue to be an option for women with this disease.
“We will continue to discuss the data from the more than 2,400 women who participated in three Phase III studies with the FDA. This recommendation does not impact Avastin’s approved uses for other cancer types.”
Genentech said that the recommendation does not impact the use of Avastin for advanced breast cancer in other countries.