FDA panel votes 5-4 against Avastin's approval for breast cancer

WASHINGTON An advisory panel for the Food and Drug Administration told the agency that Genentech’s colon and lung cancer drug Avastin should not be approved to treat advanced breast cancer, according to the wallstreetjournal.com.

The FDA typically follows the recommendations of its expert panels, but yesterday’s vote was only passed by one vote, 5-4. The company wants to market Avastin as a first-line treatment for patients with recurrent or metastatic breast cancer, based on a study sponsored by the National Cancer Institute. The NCI study compared patients taking Avastin along with the chemotherapy drug Taxol, to people taking Taxol alone.

The trial showed an apparent benefit for Avastin. Patients taking the drug had a median increase of 5.5 months in how long they lived without the disease getting worse. Median “progression-free survival” was 11.3 months with Avastin, and 5.8 months without it.

But FDA officials questioned some aspects of the drug. The agency stressed that patients taking Avastin in the main NCI study overall didn’t live significantly longer. It also said Avastin didn’t show a clear benefit in a separate study in patients with metastatic breast cancer that had previously been treated.

Several panel members said the lack of a proven survival benefit left questions about whether the drug was truly helping patients. “Our approval would rest completely on buying into progression-free survival,” said Ralph D’Agostino, chairman of the mathematics and statistics department at Boston University. “I don’t think we have that ability at the moment, given the data that’s before us.”

Other members said they felt there was meaningful evidence that Avastin could help patients, and an overall survival advantage can be difficult to prove when people may get multiple other therapies as their cancers progress.

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