Friday October 20th 2017

Avastin Removed from FDA Breast Cancer Approved Drug List

Free News Press – On Friday the U.S. Food and Drug Administration (FDA) revoked their earlier approval of the drug Avastin for use with breast cancer patients. The drug will still be available and is approved for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).

FDA Commissioner Margaret A. Hamburg, M.D., said the decision was difficult. “FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments,” Dr. Hamburg said. “But patients must have confidence that the drugs they take are both safe and effective for their intended use.”

The recent studies did not provide any evidence that Avastin would delay tumor growth in women with metastatic breast cancer. The drug included risks and some dangerous side effects, including extreme blood pressure, bleeding and hemorrhaging, heart attacks and even heart failure. There could also be perforations in different parts of the body such as the nose, stomach, and intestines.

In her 69 page opinion, Hamburg explained that the FDA examined four clinical trials involving Avastin used in combination with the cancer drug paclitaxel for those patients with HER2-negative breast cancer.

In December 2010 the FDA began a process to remove the breast cancer indication from the Avastin label, and in June 2011 they held a series of hearings to discuss the clinical trials. “The drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients,” the agency said in their statement.

“I encourage Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug,” Dr. Hamburg said in her closing statement.

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