FDA Commissioner Revokes Approval of Bevacizumab for Metastatic Breast CancerOn November 18, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg announced her decision to revoke the agency’s approval of the drug bevacizumab (Avastin) for the treatment of metastatic breast cancer. The FDA Center for Drug Evaluation and Research (CDER) granted bevacizumab accelerated approval for this indication in February 2008 with the condition that Genentech, the drug’s manufacturer, perform two confirmatory clinical trials.
“Unfortunately, the additional studies failed to confirm Avastin’s initial promise,” said Dr. Hamburg at a press briefing explaining the revocation. The two trials showed that bevacizumab delayed tumor growth slightly but did not improve survival or patients’ quality of life.
Based on these findings, CDER’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 1 in July 2010 to recommend that the FDA withdraw its accelerated approval for metastatic breast cancer. Following an appeal from Genentech in July of this year, ODAC upheld its recommendation to withdraw approval for the indication.
“Sometimes, despite the hopes of investigators, patients, industry, and even the FDA itself, the results of rigorous testing can be disappointing,” said Dr. Hamburg at the press briefing. “This is the case with Avastin when used for the treatment of metastatic breast cancer.” In light of the potentially severe side effects of bevacizumab, including heart attack or heart failure, severe high blood pressure, and bleeding or hemorrhaging, “it is clear there is no proof of a benefit in breast cancer patients that would justify those risks,” Dr. Hamburg explained.
Bevacizumab is still approved for the treatment of metastatic colorectal cancer and kidney cancer, advanced non-small cell lung cancer, and glioblastoma. Dr. Hamburg stressed that the “FDA doesn’t regulate the practice of medicine,” so a final decision on whether to use bevacizumab for metastatic breast cancer will be up to a patient and her doctors. “I urge women who are currently taking the drug for breast cancer to discuss the risks and benefits…with their oncologist,” she added.
Future studies may identify subsets of patients with metastatic breast cancer who would benefit from bevacizumab. “I would really be very pleased to see Genentech pursue those studies, and we would of course be very open to the submission of a new application that would include additional data, including support for the notion of a subset of responders to the use of Avastin,” Dr. Hamburg concluded.
Further Reading: “Progression-free Survival: Patient Benefit or Lower Standard?”
NCI Cancer Bulletin for November 29, 2011 - National Cancer Institute