FDA Grants Priority Review for Schering-Plough's Peginterferon Alfa-2b for the Adjuvant Treatment of Patients With Stage II... (growths.Interferon alfa-2b has similar a...)

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FDA Grants Priority Review for Schering-Plough's Peginterferon Alfa-2b for the Adjuvant Treatment of Patients With Stage III Melanoma

Date:1/31/2008

growths. Interferon alfa-2b has similar actions to natural interferon. Pegylated interferon alfa-2b is a longer-acting form of interferon made by attaching an inert molecule called polyethylene glycol, or PEG, to the alpha interferon 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.

Peginterferon alfa-2b is not approved for treatment of melanoma. In the United States, peginterferon alfa-2b, marketed as PEGINTRON(TM), is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age.

In the EU, peginterferon alfa-2b and ribavirin combination therapy is approved for the treatment of chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV, including naive patients with clinically stable HIV co-infection and in patients who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy. Peginterferon alfa-2b had previously received centralized marketing authorization and is marketed as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with chronic hepatitis C.

In the malignant melanoma trial and other clinical studies, patients receiving peginterferon alfa-2b experienced mild-to-moderate or severe/life-threatening side effects. The most common side effects of peginterferon alfa-2b are: flu-like symptoms, including headache, fatigue, aches and pains, fevers and chills; depression, nausea, loss of appetite and diarrhea; insomnia; alopecia (hair loss); a reaction at the site of injection; changes in blood liver function tests and in blood c
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FDA Grants Priority Review for Schering-Plough's Peginterferon Alfa-2b for the Adjuvant Treatment of Patients With Stage II...(growths.Interferon alfa-2b has similar a...)