Posted by Michael Wonder on 14 Jun 2023
Ipsen announces US FDA submission acceptance of its supplemental new drug application for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma
14 June 2023 - Supplemental new drug application submission based on the NAPOLI 3 Phase 3 trial.
Ipsen today announced that the US FDA has accepted its supplemental new drug application Onivyde (irinotecan liposome injection) plus 5 -luorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma.
