Ipsen’s Onivyde Fast Track’d for combo treatment for pancreatic cancer

The FDA has granted Fast Track designation for Ipsen’s (OTCPK:IPSEY) investigational use of liposomal irinotecan (ONIVYDE) in combination with 5-fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX), together known as NALIRIFOX, for patients with previously untreated, locally advanced and metastatic pancreatic ductal adenocarcinoma (PDAC).

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

The final analysis from the Phase 1/2 study will be presented at the virtual ESMO World Congress on Gastrointestinal Cancer on July 1.

Ipsen has exclusive commercialization rights for the current and future indications for ONIVYDE in U.S. Servier, an international pharma company, and is responsible for the commercialization outside the U.S. and Taiwan.

https://seekingalpha.com/news/3583673-ipsens-onivyde-fast-trackd-for-combination-treatment-for-pancreatic-cancer