FDA Approves Onivyde® Regimen as First-Line Therapy for Metastatic Pancreatic Cancer

The FDA has approved Ipsen's Onivyde regimen, NALIRIFOX, as a first-line treatment for metastatic pancreatic adenocarcinoma (mPDAC) based on the Phase III NAPOLI 3 trial, where it demonstrated significant improvements in overall survival and progression-free survival compared to the current standard of care. This marks the first positive Phase III trial in first-line mPDAC to show superior overall survival versus the currently approved regimen of nab-paclitaxel and gemcitabine. Onivyde is the only FDA-approved treatment regimen to demonstrate efficacy in two Phase III trials across lines of therapy in mPDAC. Pancreatic adenocarcinoma is a challenging disease with limited treatment options, and this approval represents a significant advancement in the treatment landscape for patients with mPDAC.