The Food and Drug Administration has approved peginterferon alfa-2b for adjuvant treatment of melanoma in patients with "microscopic or gross nodal involvement within 84 days of definitive surgical resection, including complete lymphadenectomy."

The drug, to be marketed as Sylatron by Schering Corp., a Merck & Co. subsidiary, is the second melanoma drug to receive FDA approval this year. The first, ipilimumab (Yervoy), was the first drug ever to improve survival of metastatic melanoma in a clinical trial.

Dr. Eric Rubin, Merck's vice president of clinical oncology, said in a statement that the company was "pleased to offer patients with node-positive melanoma this new option [Sylatron] to treat the disease." He pointed out that Sylatron "is the first such therapy approved for the adjuvant treatment of melanoma by the FDA in more than 15 years."

The FDA based its approval on a single study, EORTC (European Organisation for the Research and Treatment of Cancer) trial 18991, "Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation Alone in Resected Stage III Melanoma," the final results of which were published in 2008 in the Lancet (2008:372;117-26).

Peginterferon alfa-2b was shown to prolong relapse-free survival in this study, which enrolled 1,256 patients with resected stage III melanoma, but investigators saw no difference in overall survival. The median relapse-free survival was 34.8 months with peginterferon alfa-2b vs. 25.5 months with observation.

Peginterferon alfa-2b is given subcutaneously, and can be self-injected by melanoma patients. The recommended dose starts at 6 mcg/kg per week for eight doses, and then tapers to 3 mcg/kg per week for up to 5 years. Premedication with acetaminophen is advised when patients start treatment.

A safety analysis in 608 patients who were treated with peginterferon alfa-2b found the most serious adverse events to be fatigue, increased ALT, increased AST, and pyrexia.

Sylatron is contraindicated in patients with a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b, and also in those with autoimmune hepatitis or with hepatic decompensation, according to Merck. There is also a boxed warning on the increased risk of depression, suicidal ideation, suicide, and other neuropsychiatric disorders, which is consistent with all interferons.

Prescribing information can be found on the FDA Web site.

04/13/11