General Information

Sylatron is a covalent conjugate of recombinant alfa-2b interferon with monomethoxy polyethylene glycol (PEG). Peginterferon alfa-2b is a pleiotropic cytokine; the mechanism by which it exerts its effects in patients with melanoma is unknown.

Sylatron is specifically indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.

Mechanism of Action

Sylatron is a covalent conjugate of recombinant alfa-2b interferon with monomethoxy polyethylene glycol (PEG). Peginterferon alfa-2b is a pleiotropic cytokine; the mechanism by which it exerts its effects in patients with melanoma is unknown.

Side Effects

Adverse events associated with the use of Sylatron may include, but are not limited to, the following:

• fatigue
• increased ALT
• increased AST
• pyrexia
• headache
• anorexia
• myalgia
• nausea
• chills
• injection site reaction

Dosing/Administration

Sylatron is supplied as a powder for reconstitution into a solution designed for subcutaneous administration. The recommended initial dose is 6 mcg/kg/week subcutaneously for eight doses, followed by 3 mcg/kg/week subcutaneously for up to five years. Premedicate with acetaminophen 500 to 1000 mg orally 30 minutes prior to the first dose of Sylatron and as needed for subsequent doses.

Clinical Trial Results

The FDA approval of Sylatron was based on an open-label, multicenter, randomized study conducted in 1,256 subjects with surgically resected, AJCC stage 3 melanoma within 84 days of regional lymph node dissection. The subjects were randomized to observation (no therapy) or to Sylatron at a dose of 6 mcg/kg by subcutaneous injection once weekly for eight doses followed by a 3 mcg/kg subcutaneous injection once weekly for a period of up to five years. The main outcome measure was relapse-free survival (RFS), defined as the time from randomization to the earliest date of any relapse (local, regional, in-transit or distant), or death from any cause. Secondary outcome measures included overall survival. The median RFS was 34.8 months and 25.5 months in the Sylatron and observation arms, respectively. There was no statistically significant difference in survival between the Sylatron and the observation arms.