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FDA Advisory Committee Recommends Approval of PEGINTRON(R) for the Adjuvant Treatment of Stage III Malignant Melanoma
Date:10/5/2009

a is the deadliest form of skin cancer. The American Cancer Society estimates that in the United States in 2009 there will be 68,720 new cases of malignant melanoma, and approximately 8,650 people will die from this disease.

About The Melanoma Trial

The efficacy and safety of PEGINTRON was assessed in a trial led by the European Organisation for the Research and Treatment of Cancer (EORTC) and implemented in 101 sites across Europe. In this randomized, controlled trial of 1,256 melanoma patients, pegylated interferon alfa-2b (N=627) vs. observational arm (N=629) had a significant and sustained impact on relapse-free survival (RFS). Median RFS was 34.8 months in the pegylated interferon alfa-2b arm vs. 25.5 months in the observational arm (p-value 0.01).

In this trial, patients receiving PEGINTRON experienced mild-to-moderate or severe side effects. The most common side effects of PEGINTRON are: fatigue, elevations in blood liver function tests, depression, flu-like symptoms (including fever and chills, headache, aches and pains, loss of appetite, nausea); a reaction at the site of injection; changes in hematology tests, including neutropenia (low neutrophil count), anemia (low hemoglobin) and thrombocytopenia.

Pegylated interferon alfa-2b is a longer-acting form of interferon alfa-2b made by attaching an inert molecule called polyethylene glycol, or PEG, to the interferon alfa-2b molecule. This modification increases the size of the interferon molecule and results in slower elimination from the body, allowing for less frequent dosing than required for standard interferon.

Pegylated interferon alfa-2b is not approved for treatment of melanoma in the U.S. and is marketed as PEGINTRON® for other indications in the U.S. Full prescribing information in the U.S. may be found at '/>"/>

SOURCE Schering-Plough Corp.
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