The approval was based on findings from the phase III NAPOLI-1 trial, which demonstrated a 1.9-month improvement in overall survival (OS) with the addition of liposomal irinotecan to 5-FU and leucovorin. In the combination arm, the median OS was 6.1 months compared with 4.2 months with 5-FU and leucovorin alone (HR, 0.67; 95% CI, 0.49-0.92; P = .012). Read more . . .
The European Commission (EC) has approved pegylated liposomal irinotecan (Onivyde) in combination with fluorouracil (5-FU) and leucovorin for patients with metastatic pancreatic adenocarcinoma following progression on a gemcitabine-based therapy.