A cancer-drug advisory panel has recommended that the Food and Drug Administration pull its approval of Avastin as a first-line treatment for a specific type of advanced breast cancer.
Panel pans Avastin as breast cancer treatment
The panel on Tuesday voted 12-1 for the removal of a label indication that identifies Avastin, manufactured by the Roche Group division Genentech, in combination with the chemotherapy drug paclitaxel as a recommended treatment for women with advanced HER2-negative breast cancer.
“We are disappointed by the committee's recommendation and believe Avastin should continue to be an option for women with this incurable disease,” said Sandra Horning, Genentech's senior vice president and global head of Clinical Development Hematology/Oncology, in a news release.
Avastin—which is also approved to treat brain, colon, kidney and lung cancers—generated nearly $6 billion in sales for Roche last year. The FDA approved the drug for use in breast-cancer treatment in 2008 based on a clinical trial that showed the drug shrank breast tumors and extended patients' lives. But agency reviewers said two follow-up trials failed to show that adding Avastin to chemotherapy treatment significantly extended patients' lives. The reviewers added that side effects of the drug—fatigue, hypertension and abnormal white blood cell levels—are a significant concern.
FDA officials will consider the advisory panel's recommendations and are expected to deliver their final decision on Avastin's fate as a breast-cancer treatment on Sept. 17.
Send us a letter