Fierce Pharma February 13, 2024
It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017.
The FDA has approved Onivyde as part of a multidrug combination dubbed Nalirifox to treat patients with newly diagnosed metastatic pancreatic cancer. Before Tuesday’s approval, Onivyde had been allowed for patients with previously treated disease since 2015.
Nalirifox marks the first new regimen approved specifically for first-line treatment of pancreatic cancer in more than 10 years, Julie Fleshman, CEO of the Pancreatic Cancer Action Network, said in a statement.
The new regimen pairs Onivyde with the chemotherapies oxaliplatin and fluorouracil, plus leucovorin. Onivyde, or liposomal irinotecan, essentially replaces the original form of irinotecan used in the older Folfirinox regimen.
Pancreatic cancer is notoriously difficult to treat....
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