The approval was supported with data from the NAPOLI 3 trial, which involved 770 patients with metastatic pancreatic adenocarcinoma who had not undergone chemotherapy in the metastatic setting. Results showed a statistically significant improvement in overall survival and progression-free survival in patients with the combo regimen.
Onivyde, a liposomal topoisomerase inhibitor, disrupts DNA replication in cancer cells by entering them through the enhanced permeability and retention effect. Ipsen bought the U.S. rights to the drug from Merrimack Pharmaceuticals in 2017. Servier holds the international rights, picked up through its $2.4 billion buyout of Shire's oncology business in 2018.
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