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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

ell counts, including leukopenia (low white blood cell count), thrombocytopenia (low platelet count) and neutropenia (low neutrophil count); thyroiditis (inflammation of the thyroid gland); and autoimmunity (production of antibodies against the body's own tissues.)

Depression and suicidal behavior, including suicidal ideation, suicidal attempts and completed suicides, have been reported in association with treatment with alfa interferons.

Important Safety Information Regarding U.S. Labeling for PEGINTRON(TM) Alpha interferons, including PEGINTRON(TM) and INTRON(R) A, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGINTRON(TM) and/or INTRON(R) A therapy.

Contraindications

PEGINTRON(TM) is contraindicated in patients with hypersensitivity to PEGINTRON(TM) or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score >6 [class B and C]) in cirrhotic CHC patients before or during treatment. INTRON(R) A (Interferon alfa-2b, recombinant) for Injection is contraindicated in patients with hypersensitivity to INTRON(R) A or any component of the product, autoimmune hepatitis, and decompensated liver disease.

Incidence of adverse events

There are no new adverse events specific to PEGINTRON(TM) as compared to INTRON(R) A; however, the incidence of some (eg, injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEGINTRON(TM) were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all wer
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SOURCE Schering-Plough Corporation
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