SILVER SPRING, MD. – In a series of three unanimous votes, a Food and Drug Administration advisory panel supported the agency’s decision to withdraw approval of bevacizumab for metastatic breast cancer.
Panelists voted 6-0 on June 29 that the available evidence does not show bevacizumab (Avastin) to be safe or effective for the first-line treatment of women with metastatic HER2-negative breast cancer, in combination with paclitaxe
The company said that no new safety signals were seen in the studies, that the drug’s adverse event profile is well-known, and that effects like proteinuria and hypertension are generally manageable. It contended that bevacizumab combined with paclitaxel had a favorable risk-benefit profile as a first-line treatment of metastatic breast cancer –and that its safety profile was in line with other first-line metastatic breast cancer treatments.
The company also said that access to the treatment should be maintained for women with triple-negative metastatic breast cancer, as they have few treatment options.
But FDA officials explained that based on the overall data, the agency decided that the benefits do not outweigh serious and potentially life-threatening risks, which can include intestinal perforations, impaired wound healing, and hemorrhages. MORE