FDA approves Ipsen’s new Onivyde regimen, as first treatment for mPDAC

14 February 2024

February 14, 2024

The US Food and Drug Administration (FDA) has approved Onivyde (irinotecan liposome), from French drugmaker (Euronext: IPN), in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX regime), for the first-line treatment of metastatic pancreatic adenocarcinoma (mPDAC).

This is the second authorization 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.

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