Avastin Breast Cancer Approval Should Be Revoked: FDA Panel

A six-person panel of FDA advisors has voted unanimously to recommend that the cancer drug Avastin lose its approval for the treatment of breast cancer, saying that side effects of Avastin, which can be lethal, override any minimal to non-existent health benefits. 

The FDA advisory committee vote, though nonbinding, reinforces a decision made by the FDA in December to revoke breast cancer approval for Avastin. The loss of approval status means that many insurance companies are likely to decline covering the drug when it is prescribed to treat breast cancer, putting it financially out of reach of most patients.

Roche’s Genetech unit, the manufacturer, has fought hard against the revocation, leading to this weeks committee hearing. The company said it is disappointed in the vote and is considering legal alternatives if the decision is not overturned at FDA.

A number of women appeared at the hearing and criticized the advisory committee for its vote, saying that the decision could lead to the deaths of thousands of women. However, a number of studies and medical experts, including those on the panel, have doubts about whether Avastin has saved any breast cancer patient’s life or is of any real use in treating breast cancer.

Avastin (bevacizumab) was approved by the FDA in 2004 for treatment of non-small cell lung cancer and colorectal cancer when combined with chemotherapy. It was then was granted accelerated approval for use with paclitaxel to treat breast cancer patients by FDA in February 2008. The drug prevents the formation of new blood vessels in tumors, starving them and inhibiting their growth.

The approval of Avastin for breast cancer treatment was based on a clinical trial finding that it slowed the growth of breast cancer tumors, at odds with the usual requirement that breast cancer treatment drugs show that they actually extend the lives of patients. As part of the accelerated approval process, Genentech, a subsidiary of Roche, had to continue two more drug trials and then submit their findings to FDA.

There are a number of potential Avastin side effects, which the FDA has decided outweigh the drug’s limited health benefits. The potential health risks of Avastin may include severe high blood pressure, heart attacks, heart failure, bleeding and hemorrhaging, and the development of perforations in the nose, stomach and intestines.

Regardless of the decision on breast cancer, Avastsin, the number one selling cancer drug in the world, will stay on the market to treat myriad forms of cancer. Even if the approval to treat breast cancer is lost, doctors are still able to prescribe it “off-label” if they believe it to be the right medication for their patient.