FDA Panel Narrowly Backs Schering's Pegintron For Melanoma

A Food and Drug Administration panel Monday narrowly backed the use of Schering Plough Corp.'s (SGP) Pegintron in patients with advanced melanoma amid concerns about drug side-effects.

The panel of outside medical experts voted 6 to 4 in favor of a question that asked if there was a favorable risk-benefit assessment for Pegintron for the treatment of patients with Stage III melanoma, or cancer that's spread to lymph nodes.

Pegintron is an injection already approved to treat liver disease and Hepatitis C in combination with another drug. It contains the same active ingredient as high-dose interferon, which is currently approved to treat patients with advanced melanoma following surgery to remove affected lymph nodes.

Schering said Pegintron would offer a more convenient once-weekly dosing option compared to high dose interferon which is given intravenously five-times a week during the initial four weeks of treatment. The product is designed to boost the body's immune system in order to fight disease.

During the panel meeting, the FDA questioned whether Pegintron drug provided enough benefit to warrant approval. The agency said Pegintron improved relapse free survival, or the time before the cancer returned, it didn't improve overall survival. The agency also said the drug carried "substantial toxicity" that included blood disorders, fatigue and depression in some patients.

Susan Arbuck, a vice president at Schering-Plough's research institute said, "we stand behind the fact that this is a better tolerated drug and the safety profile we think is very acceptable."

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]