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Genentech's Avastin: An Undeserving Target for Politicians and the Media

Panel Recommends Against Avastin for Breast Cancer
Final FDA Decision Still to Come

Report from official American Cancer Society website
Article date: 2007/12/07

An advisory panel for the US Food and Drug Administration (FDA) says the drug Avastin (bevacizumab) should not be approved for breast cancer treatment.

The Oncology Drug Advisory Committee recommended against FDA approval by a 5-4 vote Wednesday, noting that Avastin does not help breast cancer patients live longer and can cause severe side effects.

Avastin is approved to treat colon cancer and lung cancer. Studies have shown that Avastin helps patients with these cancers live longer.

Survival Not Significantly Improved

In making its recommendation, the advisory panel reviewed the results of a clinical trial involving 722 women with breast cancer that had returned after initial treatment or that had spread to other parts of their body. The women were randomly assigned to receive either Avastin plus the chemotherapy drug paclitaxel, or paclitaxel alone.

Adding Avastin to paclitaxel kept the cancer from growing for an average of 11.3 months, compared to 5.8 months for the women getting paclitaxel alone.

But overall survival was not significantly better, and women who received Avastin had more serious side effects compared to those who got paclitaxel alone. Those included high blood pressure, blood clots, heart problems, holes forming in the colon (bowel perforation) and high levels of protein in the urine, which is a sign of kidney damage. These are all known side effects of Avastin.

In a report prepared for the panel, the FDA also said Avastin treatment may have caused as many as 6 deaths.