FDA to Determine Fate of Breast Cancer Drug - Again

Genentech appealing withdrawal of Avastin to treat metastatic breast cancer

(RxWiki News) In a first ever hearing, the U.S. Food and Drug Administration is considering reversing itself on a ruling to withdraw Avastin as a drug to treat metastatic (spread outside of the primary affected organ) breast cancer.

Avastin, which received an "accelerated" approval in 2004, limits blood flow to tumors. It was orginally approved - and still is - for treating lung, kidney, colon and brain cancer. In 2008, Avastin was provisionally approved as a treatment for late-stage breast cancer.

Then in December of last year, the FDA withrew approval for the drug to be used for metastatic breast cancer based on four clinical studies showing that it didn't extend patient lives.

CNN reports that Patricia Howard, a patient, told the panel this morning, "According to that data, I should have been dead years before... I'm still in the game."

Justin Smith, an analyst at MF Global UK Ltd. told the The Washington Post with Bloomberg he thinks that the manufacturer, Genentech, has a strong case. "We can argue between survival and progression endpoints, but at the end of the day...it was a drug that was very widely used in the chemotherapy specific segment. It had a 90 percent market share, so there are clearly doctors and patients out there who think this drug works," Smith said.

When asked if the FDA action may impact the development of drugs to treat other late-stage cancers, Smith said that the need for such therapies is huge. "I think the FDA has to be very careful not to disincentivize other companies to go after these drugs because the unmet need is still so, so high."

Howard has been taking Avastin for her stage IV cancer since 2007. She told the FDA,"I never thought in the United States of America I would have to beg for a drug that keeps me alive."

The new FDA ruling on the fate of Avastin should come tomorrow.

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Review Date: 
June 28, 2011