FDA Commissioner Margaret Hamburg on Friday revoked approval of Avastin for the treatment of breast cancer, the New York Times reports.
In a 69-page decision, Hamburg said clinical trials found that Genentech's drug did not extend the lives of breast cancer patients or help control their tumors, but it did expose them to potentially serious side effects, such as hemorrhaging and severe high blood pressure.
In June, an FDA advisory committee recommended that the agency revoke Avastin's approval for treatment of the disease, but it was up to Hamburg to make a final decision. The committee said the latest studies show the drug is neither safe nor effective for the treatment of advanced breast cancer.
Hamburg on Friday said she "did not come to this decision lightly. Sometimes despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing." She added, "It is clear there is no proof of a benefit in breast cancer patients that would justify the risks of Avastin."
A Genentech spokesperson said the company will not challenge Hamburg's decision in court. The company plans to launch a study to find a blood biomarker to help identify women who could benefit from a combination of Avastin and paclitaxel.
Insurers weigh coverage
Because Avastin will remain on the market to treat other cancers, physicians can prescribe it "off-label" for breast cancer patients. However, FDA's decision might influence whether insurers continue to cover the drug for the treatment of breast cancer, which can cost about $99,000 annually per patient.
Aetna and UnitedHealth Group said they will continue to cover the drug for treatment of breast cancer because they follow the National Comprehensive Cancer Network's treatment recommendations. Blue Shield of California last month said it would stop covering Avastin for treatment of breast cancer but would consider exceptions. A Cigna spokesperson said the company is in the process of reviewing its coverage policy.
Brian Cook, a spokesperson for CMS, reiterated that Medicare will continue covering Avastin for beneficiaries with breast cancer. Cook said the agency "will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies" (Pollack, Times, 11/18; Neergaard, AP/San Francisco Chronicle, 11/18; Burton/Corbett Dooren, Wall Street Journal, 11/19; Stein, Washington Post, 11/18).