Schering-Plough Corp. received FDA approvalWednesday to market Intron A as an adjuvant treatmentto surgery for patients who have a high risk for recurrenceof malignant melanoma, a deadly skin cancer.
Intron A is a recombinant interferon alpha-2b thatSchering-Plough licensed from Biogen Inc., ofCambridge, Mass. The agent already is approved in anumber of indications in the U.S. and as many as 16indications worldwide, where 1994 sales of the producttotaled $426 million.
The product approval was based on a 280-patientrandomized study in which surgery to remove the tumorwas followed by treatment with Intron A or observation.Median survival was 45.8 months in the drug group vs.33.4 months for controls, while median relapse-freesurvival was 20.6 months vs. 11.8 months. Forty-sixpercent of Intron A patients were alive five years aftersurgery compared to 37 percent of observation patients.
An FDA advisory committee recommended approval ofthe drug last July.
"This is the first biological therapy to bring aboutstatistically significant increases in overall survival ofhigh-risk malignant melanoma patients and increasedrelapse-free survival," said Steve Galpin Jr., director ofcorporate communications for Madison, N.J.-basedSchering-Plough.
While there are side effects associated with the drug,most could be controlled. Nearly three-quarters of thosein the drug group tolerated a full course of therapy, whichusually encompassed 52 weeks.
In the U.S., Intron A is approved for treating hairy cellleukemia, AIDS-related Kaposi's sarcoma, condylomataacuminata and chronic hepatitis B and C. It is approved inSweden for the same indication just granted in the U.S.,and is under review in Europe for that indication.
Intron A also is in late-stage studies in a number ofcancer and viral indications.
Schering-Plough's stock (NYSE:SGP) gained $1.25Wednesday to close at $60.75. n
-- Jim Shrine
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