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ODAC Recommends Approval of Pegylated Interferon Alfa-2b for Malignant Melanoma

ODAC Recommends Approval of Pegylated Interferon Alfa-2b for Malignant Melanoma

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for pegylated interferon alfa-2b (PegIntron) in the adjuvant treatment of patients with stage III malignant melanoma.

Pegylated interferon alfa-2b is a longer-acting form of the protein interferon alfa-2b (Intron A). The drug is administered subcutaneously once-weekly via self-injection.

Schering-Plough filed the supplemental Biologics License Application (sBLA) for this indication to the FDA in September 2007.

 
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