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

October 13, 2009
Oncology, ONCOLOGY Vol 23 No 11, Volume 23, Issue 11

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.

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.