Inequalities in Drug Access for Advanced Melanoma: The Prognostic Impact Resulting From the Approval Delay of the Combined Ipilimumab/Nivolumab Treatment in Portugal.

Introduction A combination of ipilimumab/nivolumab has demonstrated a median overall survival (mOS) of 71.9 months in advanced melanoma, establishing it as the standard first-line (1L) therapy. However, the approval of this combination by the Portuguese Regulatory Authority occurred 76 months after its approval by the European Authority, leaving tyrosine kinase inhibitors as the only 1L option available for the BRAF-mutated melanoma population.