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# FDA Approves Ipsen’s Pancreatic Cancer Drug
- URL: https://www.fdaweb.com/fda-approves-ipsens-pancreatic-cancer-drug/
- Published: 2024-02-13T12:00:00.000Z
- Updated: 2026-09-14T14:22:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156346

FDA has approved an Ipsen Biopharmaceuticals NDA for Onivyde (irinotecan liposome) for use in combination with oxaliplatin, fluorouracil, and leucovorin for first-line treatment of metastatic pancreatic adenocarcinoma.

Approval was based on data from the company’s NAPOLI 3 trial (NCT04083235), a large-scale study involving 770 patients who had not previously undergone chemotherapy for metastatic pancreatic adenocarcinoma, according to an [agency release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-irinotecan-liposome-first-line-treatment-metastatic-pancreatic-adenocarcinoma?ref=fdaweb.com). The trial compared the efficacy of the newly approved regimen, referred to as NALIRIFOX, with the standard gemcitabine plus Nab-paclitaxel (Gem+NabP) treatment.

Data from from NAPOLI 3 showed evidence of the superiority of NALIRIFOX over the Gem+NabP arm. The agency says that the primary efficacy measure, overall survival (OS), showed a statistically significant improvement with a median OS of 11.1 months for patients on NALIRIFOX compared to 9.2 months for those on Gem+NabP. Similarly, progression-free survival (PFS) was markedly extended in the NALIRIFOX group, with a median PFS of 7.4 months compared to 5.6 months in the Gem+NabP group, it says.

On the safety side, FDA says the most common adverse reactions observed (greater than or equal to 20% and a significant difference between arms) included diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation, and decreased weight. Furthermore, notable laboratory abnormalities (Grade 3 or 4) associated with NALIRIFOX included decreased neutrophils, potassium, lymphocyte counts, and hemoglobin levels.