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Study of Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin (the NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma

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Trial Profile

Study of Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin (the NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 03 Aug 2023

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At a glance

  • Drugs Fluorouracil/folinic-acid (Primary) ; Irinotecan (Primary) ; Oxaliplatin
  • Indications Adenocarcinoma; Pancreatic cancer
  • Focus Adverse reactions

Most Recent Events

  • 03 Aug 2023 New trial record
  • 27 Jul 2023 According to an Ipsen Media Release, The U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application for Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin (the NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma. The Prescription Drug User Fee Act (PDUFA) goal date is 13 February 2024.

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