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

February 1, 2008

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

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.