The maker of Avastin will attempt this summer to convince the U.S. Food & Drug Administration (FDA) that it made a mistake when it decided to revoke the pricey drug’s approval as a treatment for advanced breast cancer. Roche’s Genentech division will try to convince the FDA to change its mind on Avastin during a two-day hearing beginning June 28.
The FDA announced in December 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.
The June hearing will be the first of its kind – usually, drug companies acquiesce to such FDA requests. But Roche is asserting that the FDA’s Avastin decision was a mistake, and claims the drug is an important option for women with advanced breast cancer.
“We appreciate the opportunity to continue our discussion with the FDA during a public hearing about the use of Avastin in metastatic breast cancer,” Genentech’s chief medical officer Hal Barron said in a statement released yesterday.
Avastin still holds the breast cancer indication while the appeal is pending. The drug is also approved to treat a variety of other cancers, including metastatic colon cancer, non-small cell lung cancer, kidney cancer and glioblastoma multiforme, an incurable brain cancer. Those indications are not impacted by the FDA’s decision.
Even if the FDA’s breast cancer decision stands, doctors could still prescribe the drug off label to treat such patients. However, many insurance companies will likely refuse to cover the high cost of the drug for that purpose.
According to The New York Times, Genentech has requested that the hearing not be conducted before the FDA’s Oncologic Drugs Advisory Committee, which overwhelmingly voted last summer (12-1) to revoke Avastin’s approval for breast cancer. Genentech has argued the panel doesn’t have enough breast cancer expertise.
But according to the Times, the FDA has refused that request. “We must face the reality,” Dr. Karen Midthun, the FDA officer who will oversee the hearing, wrote in a letter to the company, “that many experts in this area have already expressed a view on this issue and/or might be considered as having conflicts because of their association with one of the parties to the hearing or competitors to Genentech.”
The hearing will take place over June 28 and 29.
Both the FDA and Genentech will present witnesses, and the panel will make a recommendation on the second day.
The final decision on Avastin’s fate will rest with the FDA Commissioner.