by Aimee Keenan-Greene

Genentech, the makers of Avastin, will get a second chance to convince the Food and Drug Administration their drug is a safe and effective breast cancer treatment.

According to Reuters, the FDA agreed to give the company a public 2-day hearing on the issue at the end of June.

Last December, The U.S. Food and Drug Administration said Avastin (bevacizumab) will no longer be approved to treat breast cancer because the drug has not been shown to be safe and the risks outweigh the benefits.

The move comes after the FDA reviewed the results of four clinical studies involving breast cancer and Avastin last July. They determined the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression. 

Other risks from taking Avastin include severe high blood pressure; bleeding and hemorrhage; the development of perforations in the body, including in the nose, stomach, and intestines; and heart attack or heart failure. 

Avastin has also been linked with several other serious and potentially life-threatening side effects including the risk of stroke, wound healing complications, organ damage or failure; and the development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS), characterized by high blood pressure, headaches, confusion, seizures, and vision loss from swelling of the brain.

Avastin itself is not being removed from the market and will not affect its approval for treating colon, brain, kidney and lung cancers.

Genentech says removing the breast cancer indication would not prevent doctors from using it in such women, but it would likely give health insurance companies a reason to deny payment. Genentech would not be able to promote Avastin for that use, according to Reuters.

Meantime, Medical News Today says the United Kingdom's regulatory board, has rejected Avastin (bevacizumab) for the treatment of patients suffering from metastatic breast cancer because there is not enough proof that the drug is truly beneficial in upping survival rates.

A recent article in the Journal of the American Medical Association says fatal adverse events (FAEs) have been reported in cancer patients treated with the widely used angiogenesis inhibitor bevacizumab (Avastin) in combination with chemotherapy.

Researchers say when bevacizumab is used in combination with chemotherapy or biological therapy, treatment-related mortality increases, compared to chemotherapy alone.