FDA Approves Avastin as Breast Cancer Drug

February 25, 2008

(Long Island, N.Y.) The Food and Drug Administration Bureau shocked experts in the medical field last Friday when it released clearance for the drug Avastin made by Genetech as a breast cancer treatment after an advisory panel of the bureau made recommendations to the opposite.

Last year, specialists convened to determine the effectiveness of Avastin as a breast cancer treatment for the FDA. Although results did show minimal slowing in growth of the tumors by using Avastin, the drug failed to improve patient condition or to diminish the cancerous tumor entirely. Subsequently they voted 5 to 4 against the approval of Genetech’s request and provided the results of their study to the FDA with their recommendation.

“All they had was progression-free survival in one trial, no increase in quality of life and patient deaths in the Avastin group,” said Fran Visco, President of National Breast Cancer Coalition. “We’re very confused why the FDA made this decision.”

Health experts fear that the decision made by the FDA to approve Avastin with very little proof of affectivity could set as precedence for other pharmaceutical companies with similar products to push for approval by the bureau thereby lowering the standards of breast cancer treatment in the market from the initial object of complete recovery to merely survival.

“If the FDA sets a precedent of approving a drug based on progression free survival, people are afraid they may stop looking at survival as the most important endpoint,” said Dr. Kay Dickersin, director of the Center for Clinical Trials at Johns Hopkins University.

Meanwhile, the Breast Cancer Organization was optimistic of Avastin’s approval for breast cancer treatment as a new option for patients. “The benefits we’re looking at here matter because they give patients hope,” said Margaret C. Kirk, the group’s chief executive. “Without disease progression they may survive to see a discovery that can help them.”

Posted by News LI Editor · Edited by Brianna - Filed Under Health