Ever since federal regulators took a first step in December to revoke approval for the breast cancer drug Avastin, activists have pleaded for authorities to reconsider.
And now, in an unusual move, a Food and Drug Administration advisory committee has reconsidered the decision — and rejected Avastin for breast cancer treatment once again.
The unanimous stance taken Wednesday by the six-member panel was based on the FDA’s assessment that Avastin provides little or no benefit for treating breast cancer. At the same time, as The Washington Post reports, the drug is believed to put women at risk for potentially life-threatening complications, including high blood pressure, hemorrhages and heart attacks.
The final decision rests with FDA Commissioner Dr. Margaret A. Hamburg, but it would be unusual for her to reject the panel’s position.
The decision came at the end of a two-day meeting marked by unusually tense exchanges between representatives of Genentech, the drug’s maker, and FDA officials. Protestors demonstrated outside the agency’s FDA headquarter during the sessions, carrying signs with messages such as, “I question the FDA’s right to take life from a woman,” and accusing budget-conscious government bureaucrats of rationing health care.
Although the panel’s recommendation is being criticized by advocates who maintain that Avastin helps some breast cancer patients, others — including several leading breast cancer advocacy groups — supported the decision, saying it was important for the agency to base its decisions on the scientific evidence, not emotional appeals.
Avastin was approved by the FDA for treating breast cancer in 2008 under a program designed to make advances in treatment available to patients quickly. The move to withdraw approval, however, came after later tests failed to back up the promise Avastin showed early on.
Genentech issued a news release expressing hope that Hamburg “does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options.”
Before the FDA took the first step to revoke Avastin’s approval for breast cancer treatment in December, the drug was being prescribed annually to about 17,500 U.S women with breast cancer. It remains the world’s top-selling cancer drug, and still is approved for treating colorectal, lung, kidney and brain cancers.