FDA: Avastin Unsafe, Ineffective Breast Cancer Treatment

Patients protest FDA's recommendation, calling it a "life-or-death" decision

The U.S. Food and Drug Administration (FDA) has recommended that the drug Avastin (bevacizumab) no longer be used to treat breast cancer, saying it is neither a safe nor effective weapon against the disease.

Though the decision is supported by many in the medical community, some doctors say Avastin should remain available. Meanwhile, patients for whom the drug has proven effective are left wondering how this will affect their prognosis.

The FDA’s recommendation does not impact Avastin’s use for other forms of advanced cancer, such as colon, lung, kidney and brain cancer. While doctors may continue to prescribe Avastin for breast cancer patients as an off-label use, insurance companies may not be able to cover it. This would leave patients wanting to continue treatment with an $8,000 a month out of pocket price tag.

After reviewing four clinical studies of Avastin in breast cancer patients, the FDA found that the drug does not prolong survival in breast cancer patients. They also found that the benefits of Avastin did not outweigh the risks. According to their findings, the drug carries a significant danger of side effects including severe hypertension, bleeding, hemorrhaging, heart attack, heart failure, and the development of perforations in the nose, stomach, intestines and other areas of the body.

“Given the number of serious and life-threatening side effects, the FDA does not believe there is a favorable risk-to-benefit ratio,” said Richard Pazdur, M.D., the FDA's chief of cancer drug review. In the wake of the FDA’s ruling, the European Medicines Agency announced on Thursday that Avastin would remain available to breast cancer patients throughout the European Union, but only when taken in combination with another drug, Taxol (paclitaxel).

On Thursday, Avastin's manufacturer Genentech/Roche, which opposes the recommendation, said it would request a public hearing to contest it. The company has 15 days to file for the review. Meanwhile, breast cancer patients and advocates, led by survivor Christi Turnage, have gathered nearly 9,500 signatures on a petition to the FDA to keep Avastin approved. According to the FDA, the recommendation will not have any immediate effect; the drug will remain available to patients with breast cancer until the decision is finalized.

What do you think about the decision to limit Avastin’s use? Chime in below.

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