Approval of Breast Cancer Drug Avastin Revoked by FDA

By Admin on November 21, 2011 | Last updated on March 21, 2019

Last Friday, the Food and Drug Administration revoked approval of breast cancer drug Avastin. The drug is designed to slow tumor growth and prolong the lives of those diagnosed with metastatic breast cancer.

But in June, an FDA advisory panel decided that the drug's benefits don't justify its risks. It is known to cause high blood pressure, hemorrhaging and heart failure. However, studies show it only delays tumor growth by 1 to 3 months.

Even a month is a gain for many cancer patients, but the FDA believes that science justifies its decision. Still, doctors have seen the breast cancer drug work wonders on some patients, reports the New York Times.

Those doctors will still be able to prescribe Avastin, as it is still approved for use with other cancers. However, a number of insurers will no longer provide coverage, as only a select few cover off-label uses. The drug costs about $88,000 a year, according to the Times.

Medicare has said that it still plans to cover Avastin prescribed to breast cancer patients.

Genentech, the drug's manufacturer, has responded to the news by announcing plans to begin new trials. It will "evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin."

Until that study reaches completion, it's important that breast cancer patients using Avastin continually reassess their risk. They should talk to their doctors about whether they substantially benefit from the breast cancer drug and if they are more susceptible to its side effects.

Related Resources:

Copied to clipboard