The Food and Drug Administration’s Oncologic Drugs Advisory Committee voted today to move forward with its December decision to withdraw approval for the drug Avastin in the treatment of metastatic breast cancer. The committee’s vote was unanimous on the grounds that the available evidence doesn’t show that the drug is effective enough to justify serious toxic side effects, including severe high blood pressure, hemorrhage and heart failure.
“The modest magnitude of benefit in progression-free survival is not substantial enough to justify the additional toxicity,” said Brent Logan, associate professor of biostatistics at the Medical College of Wisconsin in Milwaukee who served on the committee. “These toxicities have an impact on patient quality of life.”
Although non-binding, the vote is a blow to the drugmaker, Genentech, which asked for the review — a first for the agency. The hearing, held yesterday and today at the FDA campus in Silver Spring, Maryland near Washingon DC, also drew patient advocates who demonstrated outside the building and urged the FDA to reconsider its decision.
Agency commissioner Margaret Hamburg will consider the committee’s recommendation along with public comment and final summaries from Genentech and the Center for Drug Evaluation and Research and make a final decision after the public docket closes on 28 July.