Merck melanoma drug approved

The US Food and Drug Administration (FDA) has granted marketing approval to Merck's Sylatron (peginterferon alfa-2b) melanoma treatment.

The drug, which is injected subcutaneously, is indicated for the adjuvant treatment of node-positive melanoma. Specifically, it has been cleared for use within 84 days of definitive surgical resection including complete lymphadenectomy for the treatment of melanoma with microscopic or gross nodal involvement. Patients can self-inject the drug once a week, Merck noted.

The approval was based on a single, open-label trial of 1,256 patients who had had surgery and were randomised to receive either Sylatron or observation for five years.

The primary efficacy endpoint was relapse-free survival, which had an estimated median time of 34.8 months in the treatment group and 25.5 months in the observation-only group. There was no difference in overall survival between the Sylatron and the observation arms.

The drug was developed by Schering-Plough and became part of Merck's pipeline when the two companies merged.

Sylatron is the second significant new drug for melanoma to win FDA approval in recent weeks. Last month, the FDA approved Bristol-Myers Squibb's Yervoy (ipilimumab) for the treatment of unresectable or metastatic melanoma, noting that the therapy demonstrates a 'significant improvement' in overall survival for patients whose skin cancer cannot be treated with surgery or has spread to other organs.