Cancer patients treated with Avastin are 50 percent more likely to die than those treated with chemotherapy alone, according to a new study. The same study found that when patients are treated with Avastin and certain chemotherapy drugs – taxanes or platinum medications – risks for fatal Avastin side effects like bleeding, blood clots, and bowel perforations may triple.
The new Avastin study, which is published in the February 2 issue of the Journal of the American Medical Association, was conducted by researchers at Stony Brook University Medical Center in New York. It consisted of 16 studies of 5,589 patients who were taking Avastin for solid tumors of the colon, lung, breast, prostate, kidney, or pancreas.
Patients who took Avastin had about 50 percent more fatal adverse events compared to those on chemotherapy alone. About 2.5 percent of people who took Avastin died from drug-related adverse events compared to 1.7 percent on standard chemotherapy. Hemorrhaging and a blood disorder called neutropenia were the most common causes of the deaths, along with perforation of the stomach or intestines.
When Avastin was used with chemotherapy drugs like taxanes and platinum agents, about 3.3 percent of patients experienced fatal events.
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.
The U.S. Food & Drug Administration (FDA) announced late last year that it was beginning the process to revoke Avastinâ€™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. Those risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or â€œholesâ€) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure, the agency said.
Genentech, the maker of Avastin, is appealing the FDA’s decision, and for now the drug continues to maintain its breast cancer indication.
The company has faulted this latest Avastin study because it includes data for types of cancer that are not on the FDA-approved list of uses for Avastin.
Avastin costs around $88,000 per patient a year and had about $6 billion in global sales in 2009.