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FDA Panel Doesn’t Budge on Avastin for Breast Cancer

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In an unprecedented vote Wednesday, the FDA’s advisory panel 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 U.S. government to remove its endorsement from the drug.

The vote 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drug panel voted unanimously that Avastin is ineffective, unsafe and should have its approval for breast cancer withdrawn.

It should be noted that the vote is not binding and FDA Commissioner Margaret Hamburg will make the final decision.

Avastin 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.

The FDA began steps to remove Avastin’s breast cancer approval in December, but Swiss drug maker Roche appealed 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. disclaimer: This article: FDA Panel Doesn’t Budge on Avastin for Breast Cancer was posted on Thursday, June 30th, 2011 at 5:55 pm at and is filed under Uncategorized.

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