PAL coalition member Breast Cancer Action today lambasted the FDA's decision to grant accelerated approval for Avastin® (bevacizumab), in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer. Back in December, Breast Cancer Action had applauded an FDA Advisory Committee decision to recommend that the FDA not approve the drug for metastatic breast cancer. (See PAL member Breast Cancer Action declares victory as FDA denies approval for Avastin as a breast cancer treatment) The FDA normally follows the recommendations of its advisory committees, but of course is not required to.
Below is Breast Cancer Action's press release on the issue. And here is Genentech's press release on the approval.
PATIENTS LOSE, GENENTECH WINS WITH FDA'S AVASTIN RULING
San Francisco, CA ( February 22, 2008) —Breast Cancer Action (BCA) strongly disagrees with the Food and Drug Administration's decision today giving accelerated approval to biotech company Genentech’s application to market its drug Avastin as a treatment for metastatic breast cancer at this time.
"The FDA has lowered the bar on the approval of breast cancer therapies. At a time when many questions are being raised about how the FDA approves drugs for market, today's decision is a victory for drug companies, but not for patients," BCA Executive Director Barbara A. Brenner said.
BCA has long opposed Genentech’s application, arguing that no evidence has been presented that shows Avastin improves overall survival or quality of life.
In its application to the FDA, Genentech said that a clinical trial indicated that Avastin prolongs progression-free survival. However, BCA argued – and continues to argue -- that that endpoint is meaningless because (1) it does not address the patient's quality of life during those additional months, a very real question because of some of the serious side effects a number of the women experienced, and (2) it has not been shown in this case to correlate with overall survival. The data from another trial done by Genentech's parent, Roche, has not been released, but it appears that it has the same limitations.
Breast Cancer Action is a national watchdog and advocacy organization that carries the voices of people affected by breast cancer to inspire and compel the changes necessary to end the breast cancer epidemic.