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FDA Approves Ipsen’s Supplemental New Drug Application for Onivyde® (Irinotecan Liposome Injection) Plus Oxaliplatin, Fluorouracil & Leucovorin (NALIRIFOX) for Metastatic Pancreatic Adenocarcinoma

February 14, 2024 1:19 PM | Katy Monaco (Administrator)

FDA has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy. Read More.


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