FDA Approves Irinotecan Liposome for Metastatic Pancreatic Adenocarcinoma

The FDA has approved irinotecan liposome (Onivyde; Ipsen Biopharmaceuticals, Inc.) in combination with oxaliplatin, fluorouracil, and leucovorin to treat metastatic pancreatic adenocarcinoma.¹

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Pancreatic adenocarcinoma, a form of pancreatic cancer, is the second most common gastrointestinal diagnosis in the United States. Researchers estimate that around 53,000 individuals will be diagnosed with pancreatic cancer in 2024. Among the individuals diagnosed, 80% of patients are already in the metastatic stage of the disease at diagnosis.²

Previously granted Orphan Drug Designation, the approval of irinotecan liposome offers an improved first-line treatment option for individuals diagnosed with metastatic pancreatic adenocarcinoma.¹

The approval was based on NAPOLI 3 (NCT04083235), a randomized, multicenter, open-label, active-controlled trial that assessed the efficacy of the drug among metastatic pancreatic adenocarcinoma patients that were treated with chemotherapy in the metastatic setting, prior to enrollment.¹

The study authors noted that the treatment options included irinotecan liposome 50 mg/m² as an intravenous infusion over 90 minutes, followed by oxaliplatin 60 mg/m² as an intravenous infusion over 120 minutes, followed by leucovorin 400 mg/m² intravenously over 30 minutes, followed by fluorouracil 2400 mg/m² intravenously over 46 hours, every 2 weeks. An alternative regimen was nab-paclitaxel 125 mg/m² as an intravenous infusion over 35 minutes, followed by gemcitabine 1000 mg/m² intravenously over 30 minutes on days 1, 8, and 15 of each 28-day cycle.¹

The trial included 770 individuals who were randomly assigned to receive 1 of the 2 treatments based on region, liver metastases, and ECOG performance status, according to study authors.¹

The results found that individuals who received irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin displayed a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared with individuals that received nab-paclitaxel.¹

According to study authors, the median OS for irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin was 11.1 months, compared to 9.2 months with nab-paclitaxel. The median PFS also showed results among irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin, with 7.4 months vs 5.6 months.¹

Based on the findings, researchers recommend individuals to receive a 50 mg/m² dose of irinotecan liposome administered by intravenous infusion over 90 minutes every 2 weeks.¹

The most common adverse reactions when administering irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin included diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation, and decreased weight, according to study authors.¹

References

1. FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma. U.S Food & Drug Administration. News release. February 13, 2024. Accessed February 14, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-irinotecan-liposome-first-line-treatment-metastatic-pancreatic-adenocarcinoma.
2. Pancreatic Adenocarcinoma. National Library of Medicine. News release. May 2018. Accessed February 14, 2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6140147/#:~:text=In%20general%2C%20the%20prognosis%20for,%25%20and%206%25%2C%20respectively.&text=Approximately%2080%25%20of%20patients%20have,at%20the%20time%20of%20diagnosis.