The maker of Avastin — the world’s best-selling cancer drug — will get a chance to try to overturn the recommendation of regulators that it no longer be used to treat breast cancer.
The Food and Drug Administration has scheduled a first-of-its-kind public hearing for June 28-29 at which Genentech Inc. can make its case to keep treatment of recurring breast cancer as an approved use for Avastin. “We believe Avastin is an important option for women with this disease and should remain an FDA-approved choice,” Dr. Hal Barron, chief medical officer for Genentech, said in a news release.
Genentech, a unit of the Swiss drug maker Roche, requested the hearing after the FDA announced in December that it was proposing to withdraw Avastin’s approval for treating breast cancer. The notice cited studies showing Avastin had failed to live up to its promise of extending patients’ lives. According to Genentech, Avastin is used by about half of the 29,000 patients diagnosed with metastatic breast cancer every year.
Among such patients, Avastin, paired with the cancer drug paclitaxel, “more than halved the risk of disease progression or death” Genentech said in its hearing request.
Drug companies do not usually challenge FDA recommendations and the agency has never granted a hearing request before. A federal regulation “provides for informal hearings,” an FDA spokeswoman said. “It’s not a formal evidentiary hearing.”
But as The New York Times reports, Genentech “will not get the jury it wanted.” The hearing will be in front of the FDA’s Oncologic Drugs Advisory Committee — which voted 12 to 1 last July in favor of withdrawing the breast cancer approval.
“While I understand Genentech has argued that the committee does not have appropriate expertise to address this issue, we do not interpret FDA regulations as contemplating the substitution of a different advisory committee, and we do not intend to do so,” hearing officer Dr. Karen Midthun told Genentech’s lawyers in a letter.
Sparks could fly at the hearing since some politicians and patient groups have accused the FDA of trying to limit patient options and dictate medical care. In comments on the FDA’s website, patients urged the agency to grant the hearing request.
“I am a stage IV breast cancer patient. I had a total of 11 tumors on my hip and spine, I began Avastin in September of 2010 and it is working well with me,” said a single mother of two boys. She said only two tumors showed up in a scan in November.
The proposed withdrawal does not affect other approved uses of Avastin, such as in the treatment of lung, kidney, colon and brain cancers.
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