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FDA panel: Revoke drug’s breast cancer approval
Question of the Day
SILVER SPRING, MD. (AP) - A panel of cancer experts has ruled for a second time that Avastin, the best-selling cancer drug in the world, should no longer be used in breast cancer patients, clearing the way for the government to remove its endorsement from the drug.
The unprecedented vote Wednesday by the Food and Drug Administration advisory panel comes less than a year after the same panel reached the same conclusion.
The six members of the FDA oncology drug panel voted unanimously that Avastin is ineffective, unsafe and should have its approval for breast cancer withdrawn.
“I think we all wanted Avastin to succeed but the reality is that these studies did not bear out that hope,” said Natalie Compagni-Portis, the lone patient representative on the panel.
The vote is not binding and FDA Commissioner Margaret Hamburg will make the final decision sometime after July 28. The drug is approved for multiple cancers and will still be available for breast cancer, though insurers are expected to drop coverage if it loses FDA approval.
The dramatic, contentious tone of the two-day hearing underscored the difficulty of removing an option for cancer patients, even when backed by scientific evidence.
Immediately after the final vote, patients in the audience erupted in shouts against the FDA and its experts.
“What do you want us to take!? We have nothing else!” shouted Christi Turnage, of Madison, Miss. Turnage said her cancer has been undetectable for more than two years since starting therapy with Avastin.
A spokesman for the Abigail Alliance, which advocates for access to experimental medicine, said the vote should be overruled.
“This was a kangaroo court,” said Steven Walker, the group’s co-founder. “There wasn’t one dissenting thought up there, let alone one dissenting vote.”
Assuming the FDA follows through on the withdrawal, drugmaker Roche could lose up to $1 billion in revenue for its best-selling product, which generates over $6 billion per year. Avastin is FDA-approved for various types of colon, lung, kidney and brain cancer, which are not part of the debate. Doctors will still be allowed to prescribe Avastin for breast cancer, though insurers may not pay for it. When administration fees are included, a year’s treatment of Avastin can cost $100,000.
Roche’s Genentech unit argued the drug should remain available while it conducts more research on which patients benefit most from the injectable drug. The drug is approved for breast cancer that has spread, or metastasized, to other parts of the body. Such cancer is generally considered incurable.
“The data tell us it is better for women diagnosed with metastatic breast cancer to have Avastin as an approved treatment option,” said Hal Barron, Roche executive vice president.
Wednesday’s vote came after two days of hearings that often resembled a courtroom trial, complete with testimony, cross-examination and a final jury verdict. In a public comment period Tuesday, Avastin patients and their families took the role of witnesses against the FDA.
By Andrew P. Napolitano
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