FDA

FDA Approves Breast Cancer Drug Avastin Despite Opposition by Advisory Panel

Tuesday, September 09, 2008 by: David Gutierrez, staff writer
Tags: Avastin, health news, Natural News

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(NaturalNews) In a surprise move, the FDA has disregarded the recommendation of its expert advisory panel and approved Genentech's drug Avastin as a breast cancer treatment.

The FDA almost never goes against the recommendations of its advisory panels.

Avastin was approved by the FDA in 2004 for use as a lung and colorectal cancer treatment. The drug blocks the growth of blood vessels in tumors, thus slowing tumor growth. Since 2004, it has frequently been used off-label as a breast cancer treatment, and was approved for that use in Europe even before the recent FDA decision.

In spite of this record, an FDA advisory panel voted 5-4 against approving the drug for breast cancer. While studies have shown that Avastin shrinks breast tumors, there is no evidence that it lengthens or improves the quality of patients' lives.

In a nod to the panel's concerns, the FDA approved Avastin as a breast cancer treatment only conditionally. Avastin may only be used for the most advanced (metastatic) stage of breast cancer, and the FDA may withdraw approval if Genentech does not provide new evidence that the drug is effective.

The FDA placed similar restrictions on the lung cancer drug Iressa several years ago. After more studies failed to demonstrate any benefit from the drug, the FDA asked Iressa maker AstraZeneca to remove it from the market, and the company complied.

Conditional or not, the approval of Avastin has led to speculation that the FDA may be taking a more permissive approach on approving cancer drugs, and has raised the hopes of pharmaceutical company Denedron for its prostate cancer drug Provenge.

In 2007, the FDA denied approval to Provenge, even though the advisory panel had voted 17-0 that it was safe and 13-4 that it was effective. But the FDA was concerned that the apparent benefits from the drug might have been a fluke caused by the small study size, and decided to hold out for more information.

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