Tag Archive for: Onivyde

The FDA on Tuesday approved Ipsen’s Onivyde, when used in combination with three chemotherapeutic drugs, for the treatment of newly diagnosed patients with metastatic pancreatic adenocarcinoma.

Findings from the pivotal Phase III NAPOLI 3 trial show Ipsen’s Onivyde (irinotecan liposome injection), when used as part of the investigational NALIRIFOX regimen, boosted overall survival in metastatic pancreatic ductal adenocarcinoma, the company announced Friday.

The company reported Onivyde and 5 fluorouracil/leucovorin and oxaliplatin demonstrated a statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine regimen. The study also met its key secondary endpoint of progression-free survival.