Avastin (chemical name: bevacizumab), a targeted therapy medicine, has been approved by the U.S. Food and Drug Administration (FDA) to be used in combination with paclitaxel to treat women diagnosed with HER2-negative metastatic breast cancer. The approval also says that women who are to receive the Avastin-paclitaxel combination must not have received any other chemotherapy medicines to treat metastatic breast cancer. The medicine paclitaxel is sold commercially as Taxol and Abraxane.
Avastin already was approved by the FDA to treat advanced cancers of the lung, colon, and rectum.
Avastin is an antiangiogenesis medicine. This means that Avastin works by choking off cancer cells' blood supply so they can't survive. Anti means "in opposition to," angio means "blood vessel," and genesis means "beginning."
The FDA based its decision on research that showed women diagnosed with metastatic breast cancer who got both Avastin and Taxol had more time before the cancer got worse, compared to women who got only Taxol.
Still, the Avastin-Taxol combination hasn't been shown to improve overall survival, compared to Taxol alone. This could be because the benefits of adding Avastin to Taxol are too small to influence the overall survival of women diagnosed with metastatic breast cancer. Also, Avastin has a number of potentially serious side effects, including high blood pressure, nose bleeds, and extra protein in the urine. Avastin also may increase the risk of stroke and heart problems. These side effects might contribute to the lack of improvement in overall survival.
Before the FDA approved Avastin, 5 of 9 experts on an FDA panel reviewed research on Avastin and recommended the FDA not approve Avastin to treat metastatic breast cancer. The experts against approval were concerned that the potentially serious side effects of Avastin outweighed the benefits. The FDA doesn't have to follow the vote of its expert panel and didn't do so in this case.
If you've been diagnosed with metastatic breast cancer, your doctor may recommend Avastin. That recommendation will be based on information from published research and your doctor's experience with Avastin to treat other people with breast cancer, as well as YOUR unique situation.
As with any breast cancer treatment, ask your doctor about the benefits and possible side effects and risks of Avastin. Together, you and you doctor can make the best treatment choices for YOU.
NEW YORK (Reuters) - The U.S. Food and Drug Administration (FDA) has approved Avastin for the treatment of breast cancer, Genentech announced Friday.
Most industry watchers had expected the FDA to delay a decision or reject the medicine for this use. Avastin, also known by its generic name bevacizumab, has already been approved to treat colon and lung cancer.
The FDA decision comes after the U.S. biotechnology company released study findings last week that Avastin in combination with chemotherapy significantly prolonged the progression-free survival in breast cancer patients.
An FDA advisory panel in December had narrowly voted to recommend rejecting Avastin for breast cancer, saying data from an earlier study were insufficient to establish that the benefits of the drug outweighed toxicity risks in this patient population.
Bevacizumab is one of a new class of drugs that block the formation of blood vessels that supply the cancerous tumors, shutting off its source of nourishment. The agent is a genetically engineered "monoclonal antibody" that binds to and inhibits the activity of human vascular endothelial growth factor (VEGF), which is necessary for blood vessel growth.
The drug was approved to be taken with paclitaxel for the treatment of patients with advanced breast cancer who have not started chemotherapy. A study conducted by Roche, Inc., which is working with Genentech, tested Avastin in combination with a different chemotherapeutic drug.
"With Avastin plus paclitaxel, we can increase the time a woman's cancer is kept under control, and offer a biologic option to women who previously were limited to chemotherapies alone," Dr. Kathy Miller, who led one of the pivotal Avastin breast cancer studies, said in a statement.
The business community had become wary that a more conservative FDA was going to start requiring overall survival data before approving any cancer treatments. That is considered to be a much higher bar than progression-free survival data -- or time patients live without their disease advancing.
(Additional reporting by Kim Dixon in Washington)
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