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FDA Removes Breast Cancer Indication From Avastin

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Avastin (chemical name: bevacizumab) is a targeted therapy that was approved by the U.S. Food and Drug Administration (FDA) to be used in combination with Taxol (chemical name: paclitaxel) to treat metastatic, HER2-negative breast cancer that hasn't yet been treated with chemotherapy. Since the beginning of 2011, the FDA has been considering removing the breast cancer indication. On Nov. 18, 2011 FDA Commissioner Margaret Hamburg decided to remove it.

When she announced her decision, Hamburg said available research shows that women who get Avastin to treat metastatic breast cancer risk potentially life-threatening side effects with no proof that Avastin will offer benefits. She also said there was no convincing evidence that treating women diagnosed with metastatic breast cancer with Avastin will help them live longer or improve their quality of life.

This final FDA decision comes after an FDA expert panel recommended in June 2011 that the breast cancer indication for Avastin be removed. The panel's recommendation came after 2 days of hearings that were part of an appeal by Genentech, the company that makes Avastin. In December 2010, another FDA expert panel made the same recommendation to remove the breast cancer indication for Avastin, and Genentech asked the FDA to reconsider.

Both FDA expert panels concluded that Avastin has not been shown to be safe and effective for treating metastatic breast cancer. The FDA experts noted that in studies combining Avastin with one of several chemotherapy medicines to treat metastatic breast cancer, the time before the cancer grew or spread (progression-free survival) increased only a little, and adding Avastin to chemotherapy didn't increase overall survival. This means that women in those studies lived for about the same amount of time whether or not they got Avastin. So the FDA experts recommended that the breast cancer indication be withdrawn.

Many doctors believe that the benefits of Avastin for certain women diagnosed with metastatic breast cancer are worth the risks and cost of treatment. In July 2011, a committee of experts from the National Comprehensive Cancer Network (NCCN) -- an alliance of 21 of the world's leading cancer centers -- voted to continue to support the current approval of Avastin in combination with Taxol to treat metastatic, HER2-negative breast cancer that hasn't been treated with chemotherapy. Doctors can choose to use Avastin to treat metastatic breast cancer whether or not that particular use is officially approved by the FDA.

The FDA decision to withdraw the Avastin breast cancer indication will not affect the approvals of Avastin to treat advanced cancers of the lung, colon, and rectum.

Since the June 2011 expert panel recommendation, a number of U.S. health insurance companies have decided not to cover the cost of Avastin treatment for breast cancer anymore. This final decision by the FDA to remove the breast cancer indication will make it more likely that other insurers also will decide not pay for Avastin to treat breast cancer.

Still, the day after the June 2011 FDA expert panel's recommendation was released, a spokesperson for Medicare announced that even if the Avastin breast cancer indication was removed, Medicare would continue to pay for Avastin to treat metastatic breast cancer. Medicare's announcement is important because many insurers follow Medicare's payment policies. Medicare and insurance companies often pay for treatments prescribed by doctors for a condition even if the treatment isn't FDA-approved for that specific use. The NCCN's continued support for Avastin to treat metastatic breast cancer also should help encourage some insurers to continue to pay for it despite the final FDA decision.

If you've been diagnosed with metastatic breast cancer, you and your doctor will develop a treatment plan that will likely include chemotherapy and possibly hormonal therapy and/or targeted therapy medicines. No matter which treatments are recommended for you, you may want to talk to your doctor about:

  • why each treatment is recommended (including any combinations)
  • treatment timing and sequence
  • the expected benefits, risks, and side effects of each treatment

If you're already getting Avastin and are responding to treatment, you may want to ask your doctor about both the FDA's decision and the NCCN experts' recommendations. It's likely that your doctor will recommend that you stick with your treatment plan unless it stops being effective or unacceptable side effects develop. If your insurance company will not cover the cost of your Avastin treatment, talk to someone on your medical team about your options for getting help to afford continuing treatment.

Genentech remains committed to evaluating the use of Avastin to treat metastatic breast cancer. The company plans to conduct new research focusing on identifying the women who are most likely to benefit from Avastin treatment. Stay tuned to Research News for information about any results.

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