Genentech Asks FDA for Full Hearing on Avastin

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In December 2010 the U.S. Food and Drug Administration (FDA) recommended removing the indication for Avastin (chemical name: bevacizumab) in combination with Taxol (chemical name: paclitaxel) to treat metastatic, HER2-negative breast cancer that hasn't been treated with chemotherapy.

Genentech, the company that makes Avastin, has asked for a full FDA hearing to again present currently available research on Avastin and to review plans for future research that could help both the FDA and doctors better understand which patients would most benefit from Avastin to treat advanced-stage breast cancer.

The FDA made its recommendation to remove the Avastin breast cancer indication because it said Avastin hasn't been shown to be safe and effective for that use. Removing that indication would be a process and the full hearing requested by Genetech is the first step in that process. The medicine itself is not being removed from the market and the recommendation should not have any immediate affect on its use as a breast cancer treatment. The FDA's recommendation to remove the breast cancer indication also doesn't affect Avastin's approvals to treat advanced cancers of the lung, colon, and rectum.

Avastin is a targeted therapy medicine that is given intravenously. Avastin works by blocking the growth of new blood vessels that cancer cells need to grow and function. A protein called vascular endothelial growth factor (VEGF) makes new blood vessels grow in cancer cells. Avastin blocks the VEGF protein.

The FDA has these concerns about using Avastin to treat metastatic, HER2-negative breast cancer:

  • Although research showed that combining Avastin with one of several chemotherapy medicines lengthened the time before the cancer grew or spread (progression-free survival), this benefit was small and overshadowed by the risk of serious side effects.
  • Adding Avastin to chemotherapy didn't increase overall survival -- this means that women lived for about the same amount of time whether or not they got Avastin; the FDA feels that the small improvement in progression-free survival with no improved overall survival isn't a meaningful benefit, especially when the risk of serious side effects was considered.
  • Adding Avastin to chemotherapy didn't ease metastatic breast cancer symptoms.

Side effects of Avastin include high blood pressure, bleeding (nosebleeds, for example), and extra protein in the urine. People treated with Avastin also may have weakness, pain, and diarrhea. Avastin also may cause other serious side effects, including a higher risk of stroke or heart problems, kidney malfunction, and reduced white blood cell count (neutropenia), which can increase the risk of serious infection.

Still, many doctors believe that the benefits of Avastin for certain women diagnosed with metastatic breast cancer are worth the risks and cost of treatment. Doctors can choose to use Avastin to treat metastatic breast cancer whether or not that particular use is officially approved by the FDA. Still, loss of approval can make it less likely that insurers will pay for Avastin to treat breast cancer.

Some of Genentech's proposed new research will try to find genetic or other factors that might make it easier for doctors to figure out which women are most likely to benefit from Avastin.

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 the FDA recommendation. 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.

Stay tuned to Breastcancer.org Research News for updates on the FDA Avastin hearings.

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