Schering-Plough Corp. (NYSE: SGP) announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for PEGINTRON® (pegylated interferon alfa-2b) in the adjuvant treatment of patients with Stage III malignant melanoma.
PEGINTRON is a longer-acting form of the protein interferon alfa-2b (INTRON® A). PEGINTRON is administered subcutaneously once-weekly via self-injection.
"Treating malignant melanoma remains a challenge given the limited treatment options that are currently available," said John M. Kirkwood, M.D., Director of the Melanoma Center and Professor and Chief of the Division of Medical Oncology at the University of Pittsburgh School of Medicine, Pittsburgh. "Today's positive recommendation of pegylated interferon alfa-2b by the committee represents an important step toward a potential new option in the treatment of Stage III malignant melanoma, especially as the incidence of the disease continues to increase."
The FDA generally follows the recommendations of its advisory committees, although it is not required to do so. Schering-Plough filed the supplemental Biologics License Application (sBLA) for this indication to the FDA in September 2007.
"The committee's positive recommendation for PEGINTRON is an encouraging development toward the future treatment of melanoma," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "Schering-Plough remains committed to developing new therapies for the treatment of malignant melanoma, as well as for advancing the understanding and prevention of this aggressive form of cancer."