Priority Review Granted for Peginterferon Alfa-2b to Treat Stage III Melanoma

The US Food and Drug Administration (FDA) has accepted the peginterferon alfa-2b (PEG-Intron) supplemental Biologics License Application (sBLA) for for review and has granted Priority Review status to the drug for the adjuvant treatment of patients with stage III melanoma. Schering-Plough submitted its application to the agency in the fall of 2007.The application will be discussed by the FDA Oncology Drugs Advisory Committee in March.

Peginterferon alfa-2b is not approved for treatment of melanoma. In the United States, peginterferon alfa-2b is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon-alpha and who are at least 18 years of age.