Schering-Plough Corp. (NYSE: SGP) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.
Schering-Plough will work closely with FDA to respond to outstanding concerns related to the PEGINTRON melanoma filing.
In early October, the FDA's Oncologic Drugs Advisory Committee recommended approval of PEGINTRON in this indication by a vote of 6 to 4. Schering-Plough had sought approval for this indication based on data from the largest positive adjuvant trial in subjects with stage III melanoma.
Introducing new drugs to treat malignant melanoma remains a challenge, and Schering-Plough is committed to the treatment of this aggressive form of cancer.