Two cancer drugs fail FDA panel approval, but not coverage

 @ibtimes
on July 01 2011 11:53 AM
Worker at Roche
A worker makes its way on a bridge at Swiss pharmaceutical company Roche plant. REUTERS

After failing to get approval from a six-member United States Food and Drug Administration panel of cancer experts on Wednesday, federal healthcare insurer, Medicare, agreed to continue covering two drugs that treat cancer.

Advocates of the controversial drug, Avastin, a treatment for progressive breast cancer, have called the treatment a life-saver although the FDA panel agreed that the drug was not effective, caused dangerous side effects and ruled that its approval by the agency in 2008 should be revoked.

The Centers for Medicare and Medicaid Services announced Thursday that based on the evidence, provided by pharmaceutical companies, Genentech Inc., maker of Avastin and Dendreon Corp., maker of Provenge, often prescribed to treat prostate cancer, they found to be suitable to use for cellular immunotherapy treatment, which aims to improve the health of Medicare beneficiaries with prostate and breast cancers.

According to the American Cancer Society, 240,000 new cases of prostate cancer are diagnosed each year in the U.S. and the disease claims over 33,000 lives annually. CMS' decision would ensure that men and women will be able to take the drug through the government-backed health care plan that covers seniors.

The FDA decision, when it comes, does not affect CMS, Don McLeod, a spokesman for the Centers for Medicare and Medicaid (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.

A final decision as to whether Avastin will lose its approval for treatment of advanced breast cancer will be made sometime after a public comment period ending on July 28 by FDA commissioner Dr. Margaret A. Hamburg, the New York Times reported.

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