Sylatron™ receives FDA approval based on the EORTC 18991 trial

Based on the EORTC 18991 trial, the United States Food and Drug Administration approved Sylatron™, pegylated interferon α-2b, on 29 March 2011 for the treatment of melanoma patients with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.

The EORTC 18991 trial was an open label, multicenter trial that enrolled 1256 patients. Patients who had been adequately surgically resected for their primary cutaneous melanoma and affected regional lymph nodes were randomized to receive either Sylatron™ or observation for a five year period. Based on 696 relapse-free survival events, an improvement in relapse-free survival 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 relapse-free survival was 34.8 months (95% CI: 26.1, 47.4) in the Sylatron™ arm and 25.5 months (95% CI: 19.6, 30.8) in the observation arm, respectively. There was no difference in overall survival between the Sylatron™ and the observation arms [hazard ratio 0.98 (95% CI: 0.82, 1.16)].

Clinical results for this study were published by Eggermont et al. ¹as were the health-related quality of life and symptoms².

 John Bean

1 A.M.M. Eggermont, S. Suciu, M. Santinami, A. Testori, W.H.J. Kruit, J. Marsden, C.J.A. Punt, F. Sales, M. Gore, R. Mackie, Z. Kusic, R. Dummer, A. Hauschild, E. Musat, A. Spatz, U. Keilholz, for the EORTC Melanoma Group. Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: Final results of EORTC 18991, a randomised phase III trial. Lancet 372 (9633): 117-126, 2008.

2 A. Bottomley, C. Coens, S. Suciu, M. Santinami, W. Kruit, A. Testori, J. Marsden, C. Punt, F. Sales, M. Gore, R. Mackie, Z. Kusic, R. Dummer, P. Patel, D. Schadendorf, A. Spatz, U. Keilholz, A.M.M. Eeggermont. Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma: A Phase III Randomized Controlled Trial of Health-Related Quality of Life and Symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol. 27 (18): 2916-2923, 2009.