FDA approves Schering-Plough's skin cancer treatment

GAITHERSBURG, Md. A Food and Drug Administration advisory committee has recommended approval of a biotech drug to treat skin cancer.

The FDA’s Oncologic Drugs Advisory Committee voted six-to-four Monday to recommend approval for Schering-Plough Corp.’s Pegintron (pegylated interferon alfa-2b) as an adjuvant treatment for stage 3 malignant melanoma. The drug, a long-acting form of the protein interferon alfa-2b is administered weekly by self-injection and already approved as treatment for hepatitis C.

“Treating malignant melanoma remains a challenge given the limited treatment options that are currently available,” University of Pittsburgh School of Medicine professor and Division of Medical Oncology chief John Kirkwood said in a statement. “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 3 malignant melanoma, especially as the incidence of the disease continues to increase.”

FDA advisory committees’ recommendations do not mandate approval of a drug, but the agency weighs them when considering whether to grant final approval.