|FDA Panel votes against Roche's Avastin breast cancer drug|
|By Staff and Wire Reports|
|Wednesday, 29 June 2011 18:59|
Due to a panel of cancer experts ruling against Roche Holding Ltd. (OTC:RHHBY) drug Avastin, for the second time, the U.S. Government has removed its endoresment of the best-selling cancer drug in the world since the panel has ruled it should no longer be used in best cancer patients.
The FDA advisory panel came to the same conclusion it reached less than a year ago which voted that Avastin is ineffective, unsafe and should have its approval for breast cancer revoked. The drug is approved for multiple cancers and will still be available for breast cancer, though most insurers are expected to drop coverage if it loses FDA approval. Margaret Hamburg, the FDA Commissioner, will make the final decision.
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.
Immediately after the final vote, patients in the audience erupted in shouts against the FDA and its panelists.
After more than 14 hours of discussion, panelists ultimately sided with the government, saying that Avastin's ability to slow tumor growth, which is measured through medical imaging scans, has not translated into meaningful benefit for breast cancer patients.
A spokesman for the Abigail Alliance, which advocates for patient 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."
If the FDA follows through on the withdrawal, Roche Holding Ltd. (OTC:RHHBY) 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.
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