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FDA Expert Panel Brings Hammer Down on Avastin

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Washington, DCIn a unanimous vote late yesterday, an expert panel under the auspices of the US Food and Drug Administration (FDA) rejected a plea by pharmaceutical manufacturer Genentech to abandon the agency's intent to revoke approval of Avastin for breast cancer treatment.

This, in spite of a rallying cry of support from some cancer patients who petitioned the FDA to allow Avastin to retain its approval for breast cancer treatment. While doctors have the authority to prescribe drugs off-label, it is doubtful that Avastin—at about $88,000 a year for treatment—would continue to be supported by Medicaid, Medicare or private health insurance plans once given the figurative boot by the FDA.

According to an Associated Press (AP) report appearing in Forbes yesterday, this is the second time that an expert panel has voted Avastin down. In fact, the six members of the FDA oncology panel reached the exact same conclusion a year ago—that Avastin was ineffective for breast cancer. Side effects made it unsafe. With risks outweighing the benefits for that indication, the FDA panel recommended yet again that approval for Avastin be revoked for breast cancer treatment.

WebMD noted on June 29 following the vote that Avastin was fast-tracked to market under a unique formula that allows drugs showing promise and destined for the sickest patients to be allowed into the market with minimal study. The capacity for that drug to retain approval would hinge on further trials that, ideally, would back up findings of initial, cursory studies.

Avastin worked for some. Heraleen Broome, a breast cancer patient who credits Avastin with keeping her alive, told MSNBC "just because it doesn't work on some people, it doesn't mean that everyone should be deprived."

However, scientists noted that further studies revealed that Avastin not only failed to help breast cancer patients survive longer, bevacizumab (Avastin's) effectiveness against cancer was reduced further when combined with other drugs.

"Now we've seen three subsequent trials that have all failed to confirm the magnitude of benefit," said Brent Logan, PhD, an associate professor of biostatistics at the Medical College of Wisconsin and a member of the FDA panel.

Scientists came to view the initial study that appeared to suggest Avastin carried benefit against breast cancer, as an anomaly.

Avastin will retain approval for other cancers. However, given the unanimous decision by the FDA panel yesterday, it appears likely that FDA approval for breast cancer indication will be revoked.

It's not a done deal, yet. Decisions by expert panels are not binding upon the FDA. Nonetheless, industry watchers expect FDA Commissioner Margaret Hamburg to support the expert panel's finding and revoke FDA approval of Avastin for breast cancer in a decision expected sometime after July 28.

Genentech rued the outcome of the vote yesterday.

"We are very disappointed by the committee's recommendation and hope the commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options," said Hal Barron, MD, the company's chief medical officer, said in a statement published by WebMD following the meeting.

The manufacturer had been planning a new clinical trial that would have been ready for release in 2016. Genentech had hoped to buy some time and persuade the expert panel to grant Avastin a five-year window pending the outcome of the trial.

However, the panel participants were not dissuaded from their views denouncing Avastin as unsafe and ineffective for breast cancer patients. While Avastin will still be available for breast cancer off-label, the cost for most patients would be prohibitive without the FDA seal of approval.



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