The maker of <"https://www.yourlawyer.com/topics/overview/Avastin-Side-Effects-Lawyers-Lawsuit-Attorney">Avastin has appealed the U.S. Food & Drug Administration’s (FDA) recent decision to begin the process to revoke the drug’s indication as a treatment for advanced breast cancer. According to a report from Bloomberg News, a Genentech spokesperson said the company requested a hearing on the FDA’s Avastin decision and expects to hear back within 30 to 60 days.
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 FDA announced last month 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.
Roche Holding AG’s Genentech division 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.
Genentech’s petition also asserts that the FDA erred in interpreting the data about Avastin and toughened its standards for approval without informing the company, The New York Times said.
Until Genetech’s appeal is decided, Avastin will retain its indication as a treatment for advanced breast cancer.