The European Medicines Agency says that it has been formally notified by Schering-Plough that the company is withdrawing a submission to get the green light for Cylatron for melanoma.

S-P’s European unit put in an application for the marketing authorisation for Cylatron (peginterferon alfa-2b) in September 2007. The drug was expected to be used for the adjuvant treatment of patients with stage III melanoma “as evidenced by microscopic, non-palpable nodal involvement”.

In its letter to the EMEA, S-P says that the withdrawal is based on the view of the agency's Committee for Medicinal Products for Human Use that the data provided were not sufficient to allow the CHMP to conclude on a positive benefit-risk balance for Cylatron at that time.

Cylatron is a big seller for S-P, which is about to merge with Merck & Co, and is marketed as a treatment for hepatitis C with the brandname Pegintron. Last week, S-P noted that the US Food and Drug Administration has approved new labelling for Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin) combination therapy for treating chronic hepatitis C in patients three years of age and older with compensated liver disease.

With the approval of this expanded indication, it is the first and only pegylated interferon combination therapy approved in the USA that is not restricted to treatment-naive patients, S-P said.