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drug panel voted unanimously that Avastin is ineffective, unsafe and should have its approval for breast cancer withdrawn.
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 FDA began steps to remove Avastin’s breast cancer approval in December, but Roche took the rare step of appealing that decision and lobbied the agency and Congress for a second hearing.
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.
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.
“Make no mistake, this hearing is a death trial, not of Avastin but of these women who rely on Avastin to say alive,” said Terry Kelley, whose wife takes Avastin for breast cancer. “You are each personally responsible for the consequences of your own vote.”
Most cancer experts say the drug should remain available for patients who are already responding well, even if its approval is withdrawn.
One potential option to keep the drug available would be for Roche to pay for it when patients have no other option. The company already provides the drug for free to patients who meet certain financial criteria or don’t have health coverage.
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