13.02.2024 - 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 .
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Approval based on Phase III NAPOLI 3 clinical trial in which Onivyde® regimen (NALIRIFOX) demonstrated statistically significant superiority and clinically.
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