Ipsen: new indication approved in pancreatic cancer

(CercleFinance.com) - Ipsen announces that the US FDA has approved the additional indication of Onivyde, in combination with oxaliplatin, fluorouracil and leucovorin as first-line treatment for adult patients with metastatic pancreatic adenocarcinoma.


In the phase III NAPOLI 3 clinical trial, this regimen demonstrated statistical superiority, as well as clinically significant improvements in overall and progression-free survival compared to treatment with nab-paclitaxel and gemcitabine.

This is the second approval of an Onivyde regimen in this disease, following the FDA's 2015 approval of Onivyde, in combination with fluorouracil and leucovorin, after disease progression following treatment with gemcitabine.


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