The FDA has issued a complete response letter to Schering-Plough’s supplemental Biologics License Application (BLA) regarding Pegintron (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.
Schering-Plough said that it would work closely with FDA to respond to concerns related to the Pegintron melanoma filing.
Pegintron is indicated in the US for use in combination with Rebetol (ribavirin) for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease. Additionally, Pegintron is also indicated in the US for use alone for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with interferon alpha and who are at least 18 years of age.
In early October this year, the FDA’s oncologic drugs advisory committee recommended approval of Pegintron in this indication. Schering-Plough had sought approval for this indication based on data from the largest positive adjuvant trial in subjects with stage III melanoma.