A major advocacy group for breast cancer patients is backing away from promoting the controversial drug, Avastin, for use in new patients. According to a report in The Wall Street Journal, the new stance by the Susan G. Komen Race for the Cure comes after the U.S. Food and Drug Administration (FDA) said it was beginning the process of revoking Avastin’s indication for advanced breast cancer, after questions were raised about its effectiveness.
The Susan G. Komen Race for the Cure lobbies for greater access to breast-cancer prevention services and treatment.
According to the Journal report, the Komen science-advisory board discussed the question of Avastin with other specialists at the annual breast-cancer symposium held in San Antonio in December. Over the fall, the organization also met with the FDA about the agency’s Avastin concerns.
While the organization will no longer push for access to Avastin for new breast cancer patients, an official with the group said it will continue to push for affordable access to Avastin for patients already on the drug.
“We will do everything we can to get insurers to keep covering this, and get Genentech to provide access, and expand, if necessary, its patient-access program,” Elizabeth Thompson, president of the Komen group, told the Journal.
The FDA announced last month that it was beginning the process to revoke Avastin’s breast cancer approval, after determining that Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh its significant risks. Avastin side effects 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, the agency said.
Genentech has appealed the FDA’s decision, asserting the agency erred in interpreting the data about Avastin and toughened its standards for approval without informing the company. In its petition, the company outlined plans for a new study of Avastin with the chemotherapy paclitaxel in the appeal it filed with the FDA yesterday. The company said recent data suggest higher levels of a protein in the blood known as VEGF-A may help identify patients who may derive substantial benefit from Avastin.
Until Genetech’s appeal is decided, Avastin will retain its indication as a treatment for advanced breast cancer.
Avastin, the best selling cancer drug in the world, was the first approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor. It was originally approved in 2004 to treat metastatic colon cancer, and in 2006, the agency approved it as a treatment for non-small cell lung cancer. In 2008, the FDA also approved Avastin as a metastatic breast cancer treatment in combination with a chemotherapy drug called paclitaxel, and in 2009, it was approved to treat kidney cancer, as well as glioblastoma multiforme, an incurable brain cancer.