FDA approves Ipsen pancreatic cancer combo drug

Feb. 14, 2024

The FDA has approved Ipsen's Onivyde (irinotecan liposome) in combination with oxaliplatin, fluorouracil and leucovorin as a first-line treatment for metastatic pancreatic adenocarcinoma, a particularly aggressive form of cancer with limited treatment options and a poor prognosis.

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.

Onivyde was granted Orphan Drug designation for the metastatic pancreatic adenocarcinoma indication in the U.S. The drug is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil and leucovorin for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.