WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK - News) (known as MSD outside the United States and Canada) today announced that the U.S. Food and Drug Administration (FDA) has approved SYLATRON™ (peginterferon alfa-2b) for injection, for subcutaneous use. SYLATRON is indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. SYLATRON is contraindicated in patients with a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b, in patients with autoimmune hepatitis, and in patients with hepatic decompensation (Child-Pugh score >6 [class B and C]).
“Merck is pleased to offer patients with node-positive melanoma this new option to treat the disease,” said Eric Rubin, M.D., vice president of clinical oncology at Merck. “This is the first such therapy approved for the adjuvant treatment of melanoma by the FDA in more than 15 years. Merck remains committed to further innovative research to help people suffering from cancer.”
The risk of serious depression, with suicidal ideation and completed suicides, and other serious neuropsychiatric disorders are increased with alpha interferons, including SYLATRON. SYLATRON should be permanently discontinued in patients with persistently severe or worsening signs or symptoms of depression, psychosis, or encephalopathy. These disorders may not resolve after stopping SYLATRON.
SYLATRON is a once-weekly subcutaneous injection that may be self-injected. The recommended dose is 6 mcg/kg/week subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously for up to 5 years. Patients should be premedicated with acetaminophen 500 to 1000 mg orally 30 minutes prior to the first dose of SYLATRON and as needed for subsequent doses.
The Prescribing Information for SYLATRON recommends the following dose modifications that are based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 2.0):
* SYLATRON should be permanently discontinued for: persistent or worsening severe neuropsychiatric disorders; grade 4 non-hematologic toxicity; inability to tolerate a dose of 1 mcg/kg/week; new or worsening retinopathy. * SYLATRON should be withheld for any of the following: absolute Neutrophil Count (ANC) <0.5x109/L; platelet Count (PLT) <50x109/L; ECOG PS =2; non-hematologic toxicity = Grade 3. * SYLATRON should be resumed at a reduced dose (see Table 1 below) when all of the following are present: absolute Neutrophil Count (ANC) =0.5x109/L; platelet Count (PLT) =50x109/L; ECOG PS 0-1; non-hematologic toxicity has completely resolved or improved to Grade 1.
