Approval based on Phase III NAPOLI 3 clinical trial in which Onivyde® regimen (NALIRIFOX) demonstrated statistically significant superiority and clinically.
Davide Melisi, MD, PhD, discusses the potential of NALIRIFOX as a new first-line standard of care for patients with metastatic pancreatic ductal adenocarcinoma, noting that pending FDA approval, this effective and tolerable regimen could also inform future clinical trials designs for patients with pancreatic cancer.
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Frontline treatment with the combination of the CD40-directed monoclonal antibody agonist mitazalimab and modified FOLFIRINOX continued to produce responses in patients with metastatic pancreatic ductal adenocarcinoma.
Supplemental New Drug Application (sNDA) submission based on the NAPOLI 3 Phase III trial1Approval would represent expansion of treatment options in an aggressive and difficult-to-treat cancer with few