An FDA advisory panel vetoed to remove the approval of Avastin to for treating advanced breast cancer in combination with chemotherapy, citing that the benefits do not appear to exceed the risks of the drug. In December 2011, the FDA recommended against removing the breast cancer indication for Avastin, stating that the drug has not be shown to be safe or effective in breast cancer patients. The FDA commissioner will make a final ruling on whether Avastin’s approval will be removed after a public comment period closes at the end of July 2011.
Avatin has been on the market for 2 years to treat breast cancer, but an advisory panel to the FDA recommended unanimously to remove approval for Avastin in the treatment of metastatic (advanced) breast cancer because there are not enough data to show the benefits are greater than the risks of the drug. The decision is consistent with previous findings. In July 2010, researchers on the panel found no meaningful benefit for patients who took Avastin and believed the toxicity of the drug outweigh positive effects.
“We are very disappointed by the committee’s recommendation and hope the Commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options,” said Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development, in the company’s press release. “We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin.”
Many women were outraged at the panel’s decision, citing personal benefits from the drug. Analysts expect insurance companies to stop covering the cost of Avastin for breast cancer treatment if the FDA removes its approval. Thus far, insurers appear to be continuing to cover costs of the drug, according to the Centers for Medicare and Medicaid Services.
In December 2010, the FDA stated the following in a news release: The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or holes) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.
Avastin is FDA-approved to treat some colorectal, lung, brain, and kidney cancers. Last December, the FDA advised that doctors currently treating patients with Avastin for advanced breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options. According to Roche, the panel’s recommendation will not affect approval for treating these other types of cancer.
Avastin works by attacking the vascular endothelial growth factor (VEGF) in tumor cells. VEGF enables tumors to grow their own blood supplies, which spur their growth. The FDA had approved Avastin in 2008 to be used with chemotherapy that includes the drug Taxol in advanced breast cancer patients who have not undergone chemotherapy and whose cancers are not HER-2 positive. HER-2 is a protein found on the surface of breast cancer cells. Some breast cancer patients have extra copies of HER2 that can be associated with more aggressive or treatment-resistant cancers. Another drug, Herceptin, can be used to treat breast cancer patients with HER-2 positive breast cancers.
At the time the FDA had approved Avastin for breast cancer patients, its advisory panel had recommended against it, stating that Avastin had not been shown to increase patient survival. However, in approving the drug, the FDA noted that Avastin slows the progression of advanced breast cancer. In July 2010, the panel voted 12 to 1 to remove the drug’s approval for use in breast cancer patients along with chemotherapy. The panel noted that follow-up studies failed to show that it significantly increased the time breast cancer progressed.
- The FDA provided information on the hearing to withdraw approval for the Avastin on its web site, http://www.fda.gov/
- The June 30, 2011 Roche news release, “Roche provides update from FDA hearing on Avastin for metastatic breast cancer,” was posted at http://www.roche.com/media/media_releases/med-cor-2011-06-30.htm
- The December 16, 2010 FDA news release, FDA begins process to remove breast cancer indication from Avastin label , was published on the FDA web site, http://www.fda.gov/
