Merck announced that Sylatron (peginterferon alfa-2b injection) has been approved for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection, including complete lymphadenectomy. This approval was based on data from the EORTC study, an open-label, multicenter, randomized clinical trial that evaluated the safety and efficacy of Sylatron in 1,256 patients with surgically resected, American Joint Committee on Cancer (AJCC) Stage III melanoma within 84 days of regional lymph node dissection.

The study’s primary endpoint was relapse-free survival (RFS), defined as the time from randomization to the earliest date of any relapse (local, regional, in-transit, or distant), or death from any cause. Based on 696 RFS events, patients who received Sylatron showed a statistically significant improvement in RFS when compared to those randomized to observation only (hazard ratio for RFS was 0.82 [0.71–0.96]; unstratified log-rank p=0.011) in favor of patients treated with Sylatron. Median RFS was 34.8 months [26.1–47.4] and 25.5 months [19.6–30.80] in the patients treated with Sylatron compared with the patients in the observation group, respectively.

Sylatron will be available in single-use vials containing 40mcg/0.1mL, 60mcg/0.1mL, or 120mcg/0.1mL concentrations of peginterferon alfa-2b.

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