FDA panel supports approval of Schering-Plough's PegIntron for patients with melanoma

Members of an FDA advisory committee recommended approval for Schering-Plough's PegIntron (peginterferon alpha-2b) on Monday, voting 6 to 4 that the benefits of the treatment outweighed its risks in the adjuvant treatment of patients with Stage III malignant melanoma, the drugmaker announced.

In briefing documents released last week ahead of the meeting, FDA staff noted that study data provided by Schering-Plough suggested PegIntron significantly extended relapse-free survival in this population, but did not increase overall survival and was associated with a risk of "substantial toxicity."

Panellist Gary Lyman stated that he was "leaning in the direction that [the drug] may be helpful given that there are very few options for these patients." However, committee member William Kelly remarked: "I voted no because I think survival has to be the primary endpoint here."

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