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U.S. Department of Health and Human Services

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Peginterferon alfa-2b

 

On March 29, 2011, the U. S. Food and Drug Administration approved peginterferon alfa-2b (Sylatron, Schering Corporation, Kenilworth, NJ 07033), for the treatment of patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.

 

The approval was based on a single trial, EORTC 18991, an open label, multi-center trial enrolling 1256 patients.  Patients who had been adequately surgically resected for their primary cutaneous melanoma and affected regional lymph nodes were randomized (1:1) to receive either Sylatron or observation for a 5 year period. Stratification factors included type of nodal involvement (microscopic versus gross), number of positive nodes (1, 2-4, 5 or more, or not assessed), Breslow primary thickness (less than 1.5 mm, ≥ 1.5 to 4 mm, ≥ 4 mm), ulceration of primary tumor (present or absent or unknown), sex, and study center.  Patients were assessed for local and regional recurrence or distant metastases every three months for the first two years of treatment and subsequently every six months through the end of the trial.  An independent review committee, blinded to randomization assignment and to information that would break the treatment blind, reviewed the case report form data to determine the occurrence, and the date of loco-regional recurrence, or distant metastasis.

 

The primary efficacy endpoint, relapse-free survival (RFS), was defined as the time to the earliest of local or regional recurrence, distant metastases, or death. Based on 696 RFS events, an improvement in RFS for Sylatron-treated patients [hazard ratio 0.82 (95% CI: 0.71, 0.96); unstratified log-rank p = 0.011] was observed.  The estimated median RFS was 34.8 months (95% CI: 26.1, 47.4) and 25.5 months (95% CI: 19.6, 30.8) in the Sylatron and observation arms, respectively.  Following 525 deaths on study, there was no difference in overall survival between the Sylatron and the observation arms

[hazard ratio 0.98 (95% CI: 0.82, 1.16)].

 

Safety was evaluated in 608 Sylatron-treated patients in EORTC 18991.  The most common (>60%) grade 1-4 adverse reactions experienced by Sylatron-treated patients were fatigue, increased ALT, increased AST, pyrexia, headache, anorexia, myalgia, nausea, chills, and injection site reactions.  The most common serious adverse reactions occurring in Sylatron-treated patients were fatigue, increased ALT, increased AST, and pyrexia.

 

Thirty-three percent of patients receiving Sylatron discontinued treatment due to adverse reactions.  The most common adverse reactions present at the time of treatment discontinuation were fatigue, depression, anorexia, increased ALT, increased AST, myalgia, nausea, headache, and pyrexia.  Five deaths were reported within 30 days of the last Sylatron dose.  Two were attributed to recurrent disease, two to cardiovascular disease possibly related to Sylatron, and one to an accident.

 

The recommended dose and schedule for Sylatron is 6 mcg/kg/week, subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously.  The maximum treatment period is 5 years (260 weeks).

 

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5153lbl.pdf

 

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).