Avastin Label Now Reflects Risk of Ovarian Failure

According to the results of a new study, use of the popular cancer drug, Avastin, could potentially affect fertility in some women. Based on the data, the U.S. Food and Drug Administration ordered the drug’s label be updated to reflect the risk for ovarian failure, as well as the risk for additional adverse events, such as venous thromboembolic events (VTE) and osteonecrosis of the jaw.

The FDA’s request for a label change was prompted by the results of a clinical trial involving 179 women with colon cancer who were being treated with chemotherapy. Approximately half of the women were receiving both Avastin and chemotherapy, while the other half were receiving chemo only. The study showed that ovarian failure occurred in 34 percent of women receiving the combo of Avastin (bevacizumab) and chemo, compared to the 2 percent of women receiving only chemo treatments.

Avastin’s updated label now states that prior to beginning treatment, women with childbearing potential should be warned of the risk for ovarian failure. The drug is currently approved as a treatment for certain types of lung, brain, kidney, colon and breast cancer. However, late last year, an FDA advisory committee recommended that Avastin’s approval as a treatment for breast cancer be revoked, based on evidence from clinical trials that the drug failed to extend the lives of metastatic breast cancer patients.

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