FDA OKs injectable for melanoma

April 20, 2011

The Food and Drug Administration (FDA) has approved Sylatron (peginterferon alfa-2b), an injectable drug for adjuvant treatment of melanoma, manufacturer Merck has announced.

Whitehouse Station, N.J. - The Food and Drug Administration (FDA) has approved Sylatron (peginterferon alfa-2b), an injectable drug for adjuvant treatment of melanoma, manufacturer Merck has announced.

A Merck statement said 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, the company notes.

Merck warns that the risk of serious depression, suicidal ideation, suicide and other serious neuropsychiatric disorders increase with use of alpha interferons, including Sylatron. The drug “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.”

The FDA approval is based on a multicenter, randomized European study involving 1,256 patients with surgically resected stage 3 melanoma within 84 days of regional lymph node dissection. Patients were randomized to observation (no therapy) or to Sylatron at a dose of 6 mcg/kg injected once weekly for eight weeks, followed by 3 mcg/kg injected once weekly for a period of up to five years.

The study's primary endpoint was relapse-free survival (RFS), defined as the time from randomization to the earliest date of any relapse. Based on 696 RFS events, the median RFS was 34.8 months for the Sylatron patients and 25.5 months for the observation group. Overall survival (OS) was a secondary endpoint of the study, and investigators reported no statistically significant difference in OS between the Sylatron and observation groups.

The study reported that 33 percent of Sylatron patients discontinued treatment due to adverse reactions. Also, safety and effectiveness in patients younger than 18 have not been established.

In the statement, Eric Rubin, M.D., Merck vice president of clinical oncology, says, “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.”