Today, Rep. Wasserman Schultz expressed concern over the Food and Drug Administration’s (FDA) decision to pull the metastatic breast cancer indication from the Avastin (bevacizumab) label.
Despite promising early studies and accelerated approval of the drug for women with metastatic breast cancer, the FDA has reversed the decision for approval, based on evidence from two new clinical trials.
“I am disappointed in the news that the FDA wishes to end approval of Avastin for breast cancer patients. As a breast cancer survivor, I know how important it is that women have every possible cancer-fighting tool at their disposal. Most importantly, I hope that women who are on Avastin, and for whom it is working, can continue to have access to it and that their insurers will cover the drug.”
Avastin is commonly used off-label, not only to treat breast cancer, but to treat ovarian cancer as well.
While the FDA made this announcement today, the opposite conclusion has been made by the European Medicines Agency (EMEA), the European equivalent to the FDA, and the National Comprehensive Cancer Network (NCCN), a non-profit alliance of 21 of the world’s leading cancer centers; both expressed support for continued use of Avastin for breast cancer patients.
“Despite my disappointment, I applaud the FDA for recognizing that there may be a select group of patients for whom Avastin may be beneficial, and I urge the FDA and Genentech/Roche to work together on future trials. Given the conflicting response to the same data and the clear evidence that this drug truly helps some, though not all women, it is vital that we guarantee the protection of Avastin on the market. Treatment decisions should remain between women and their doctors, and we look to a future with more targeted studies that can determine the best recipients for this life-saving treatment.”
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