FDA Approves Irinotecan Liposome for Metastatic Pancreatic Adenocarcinoma

By: Dr. Anish Shah
Bronx-Lebanon Hospital; Bronx, NY


On February 13, 2024, the U.S. Food and Drug Administration granted approval for the use of irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) as a combined treatment with oxaliplatin, fluorouracil, and leucovorin. This is intended for the first-line treatment of metastatic pancreatic adenocarcinoma.


Approval was based on NAPOLI 3 (NCT04083235), a randomized, multicenter, open-label, active-controlled trial that included 770 patients diagnosed with metastatic pancreatic adenocarcinoma who had not undergone chemotherapy for the metastatic condition. Patients were randomized to receive either NALIRIFOX, including irinotecan liposome, or Gem+NabP. Irinotecan liposome was given as an intravenous infusion of 50 mg/m2 over 90 minutes, every 2 weeks, before the administration of oxaliplatin, fluorouracil, and leucovorin.


Efficacy was established on overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). Results showed statistically significant improvements in OS and PFS for the NALIRIFOX arm over the Gem+NabP arm. Specifically, the median overall survival was 11.1 months (95% CI: 10.0, 12.1) in the NALIRIFOX group and 9.2 months (95% CI: 8.3, 10.6) in the Gem+NabP group (Hazard Ratio [HR] 0.84 [95% CI: 0.71, 0.99]; p-value 0.0403). Moreover, the median PFS was 7.4 months (95% CI: 6.0, 7.7) in the NALIRIFOX group and 5.6 months (95% CI: 5.3, 5.8) in the Gem+NabP group (HR 0.70 [95% CI: 0.59, 0.85]; p-value 0.0001). The ORR was
41.8% (95% CI: 36.8, 46.9) in the NALIRIFOX group and 36.2% (95% CI: 31.4, 41.2) in the Gem+NabP group.


Common side effects included diarrhea, fatigue, nausea, vomiting, reduced appetite, abdominal discomfort, mucosal inflammation, constipation, and weight loss. Frequent laboratory abnormalities included reduced neutrophils, reduced potassium, reduced lymphocyte, and reduced hemoglobin levels.


Irinotecan liposome, in combination with oxaliplatin, fluorouracil, and leucovorin, was approved for the first-line treatment of metastatic pancreatic adenocarcinoma. The recommended dose is 50 mg/m2 administered by intravenous infusion over 90 minutes every 2 weeks, before the administration of other drugs.


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