FDA Withdraws Approval for Roche's Avastin - - BioPharm International

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FDA Withdraws Approval for Roche's Avastin


BioPharm Bulletin

An FDA panel has voted unanimously to withdraw approval for Roche’s Avastin for use in the treatment of metastatic breast cancer because there is not enough data to support the conclusion that the benefits outweigh the risks. The fate of Avastin in this indication now lies in the hands of FDA Commissioner Margaret Hamburg, who will make the final decision after the period for public comments closes at the end of July. Roche will also have the opportunity to submit its final summary on the matter.

“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, chief medical officer and head of global product development at Roche, in a statement. “We remain ready to collaborate with FDA to find a solution that is in the best interest of patients who need Avastin.” Despite the proceedings, the US Centers for Medicare and Medicaid Services (CMS) have reportedly said that Medicare will continue to pay for Avastin.

“The FDA decision, when it comes, does not affect CMS,” Don McLeod, a spokesman for CMS, told Reuters. “The drug will still be on the market, doctors will still be prescribing it, and we will continue to pay for it.”

Whatever FDA decides, Roche’s statement added that the proceedings will have no impact on Avastin’s approved uses for other cancer types in the US, or the use of Avastin for metastatic breast cancer in other countries.

Both FDA and the European Medicines Agency (EMA) scrutinized the risk–benefit profile of Avastin in 2010. In December 2010, EMA concluded that Avastin in combination with paclitaxel remained a “valuable” treatment option for women with breast cancer, but not with other combinations.

Last week, Avastin also received a broader European Union label that enables the drug to be used in combination with Roche’s Xeloda as a first-line treatment when other chemotherapies are not considered appropriate.

FDA, on the other hand, had a different opinion on the matter. In December 2010, FDA recommended that the breast cancer indication be removed from the Avastin label because the drug had not been shown to be “safe and effective for that use.” Roche appealed the ruling and refused FDA’s recommendation to voluntarily withdraw Avastin’s breast cancer indication—the first company to ever do so, according to a report from EP Vantage.

The deadline for public comments is July 28, 2011. The final decision will be made after this date.

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