Ipsen’s Onivyde® Regimen, a Potential New Standard-of-Care First-Line Therapy in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Approved by FDA; Liposome-Delivered Medicine (Irinotecan) Blocks Topoisomerase I

  • Approval based on Phase III NAPOLI 3 clinical trial in which Onivyde® regimen (NALIRIFOX) demonstrated statistically significant superiority and clinically meaningful improvements in overall survival and progression-free survival versus nab-paclitaxel and gemcitabine 1
  • NAPOLI 3 represents the first positive Phase III trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) to demonstrate superior overall survival versus the currently approved regimen of nab-paclitaxel and gemcitabine1
  • Onivyde is the only FDA-approved treatment regimen to demonstrate efficacy in two Phase III trials across lines of therapy in mPDAC1,2

On February 13, 2024, Ipsen (Euronext: IPN; ADR: IPSEY) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic ductal adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.

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