FDA revokes Avastin approval for breast cancer.
In the statement announcing the decision, FDA commissioner Dr. Margaret Hamburg said she is revoking the approval, because the use of Avastin as a first-line treatment for metastatic breast cancer has not been shown to be safe and effective.
Avastin is approved for several other types of cancers, so it will remain on the U.S. market. For some cancers, bevacizumab has been shown "by rigorous scientific testing to provide a benefit that justifies its risks," she said during a press briefing held after the announcement was made. "After reviewing the available breast cancer studies, however, it is clear there is no proof of a benefit in breast cancer patients that would justify" those risks, which include myocardial infarction, heart failure, severe hypertension, hemorrhage, and intestinal perforations, she added.
The FDA granted an accelerated approval to bevacizumab in combination with paclitaxel as a first-line treatment for metastatic breast cancer in February 2008, based on an open-label study that found a survival advantage for the combined treatment, compared with treatment with paclitaxel alone. Studies confirming the beneficial effects are a condition of accelerated approvals. In this case, though, two follow-up studies failed to confirm the benefit, and the FDA concluded that bevacizumab had an unfavorable risk-benefit profile for breast cancer and decided to withdraw its approval of the breast cancer indication.
In an unprecedented move, the manufacturer, Genentech, appealed the decision to withdraw approval and requested a hearing, which was held in July 2011. At that meeting, the FDA's Oncologic Drugs Advisory Committee unanimously voted that approval for the breast cancer indication should be withdrawn because clinical trials did not show an improvement in overall survival or any clinically meaningful improvements in progression-free survival. The final decision was left to Dr. Hamburg.
"This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use," Dr. Hamburg said in the statement. "After reviewing the available studies, it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks." Her decision is explained in a 69-page opinion.
A statement issued by Genentech after the FDA statement was released said that the company was disappointed with the outcome, remained committed to women with the disease, and would "continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment."
Despite the FDA's decision, the company said it planned to start a new phase III study of Avastin in combination with paclitaxel in women with previously untreated metastatic breast cancer, which would "evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin."
At least for now, Medicare coverage of bevacizumab will continue for breast cancer. A statement issued by the Centers for Medicare and Medicaid Services (CMS) said that CMS would "monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies."
Avastin is still approved for treating metastatic breast cancer in more than 80 countries.
Dr. Hamburg's full statement on the decision is available at www.fda.gov/ downloads / NewsEvents / Newsroom / UCM280546.pdf.
|Printer friendly Cite/link Email Feedback|
|Publication:||Family Practice News|
|Date:||Dec 1, 2011|
|Previous Article:||U.S. teen birth rate drops to historic low.|
|Next Article:||A life-changing question.|