FDA Panel Rejects Proscar and Avodart for Prostate Cancer

FDA Panel Rejects Two Drugs For Prostate Cancer Prevention.

The AP (12/2) reports, "A panel of federal health experts unanimously rejected the use of Merck's Proscar to prevent prostate cancer, saying the drug could actually raise the risk of the most serious types of tumors." The panel also decided against recommending that the label of GSK's Avodart (dutasteride) "be changed to say that they can reduce a man's risk of getting prostate cancer," the New York Times (12/2, A21, Kolata) reports. "Both are already on the market to shrink the prostate, alleviating a harmless but uncomfortable condition that results in frequent urination in older men."

        As for cancer prevention, Richard Pazdur, director of FDA's office of oncology drugs products, pointed out that the agency must "have a very high level of certainty" regarding study results because the drug, if approved, would be prescribed to relatively healthy men, the Wall Street Journal (12/2, Dooren) reported. He added, "We are talking about a population of people -- not patients -- men who don't have disease so your level of certainty...has to be heightened."

        And, the "panel agreed that a reduction in the less-risky tumors -- which may never even turn into serious cancers -- is not a big enough benefit if the drugs may actually lead to life-threatening cancers," MedPage Today (12/1, Walker) reported. But the drugmakers "argued at the meeting that their trials didn't show the drugs lead to serious prostate cancers and offered other explanations for the higher number of high-grade cancers in the treatment arms." In fact, "Merck isn't seeking an expanded indication, but the company would like the label of finasteride to detail positive results of the Prostate Cancer Prevention Trial (PCPT), which demonstrated the drug's chemopreventive potential."

        Nevertheless, "FDA regulators already had several concerns about using the medications for the prevention of prostate cancer," HealthDay (12/2) reported. "For one thing, black men, who are at high risk for the disease, were underrepresented in the clinical trials." Bloomberg News (12/2, Larkin) and Dow Jones Newswire (12/1) also covered the story.

Medved, I used Proscar to treat BPH for many years.  The first reports about the risks of agressive PCa came out about the time of my original Dx.  I have often wondered if there was any link and if so, just what the mechanism is that creates the aggressive tumors.

Carlos