It marks the awaited green light for Ipsen following its acquisition of Onivyde in 2017. The FDA has given its nod to the supplemental new drug application for Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) as a primary treatment for adults with metastatic pancreatic adenocarcinoma (mPDAC). This approval represents the second approval for an Onivyde treatment regimen in mPDAC, building upon the FDA’s 2015 approval of Onivyde alongside fluorouracil and leucovorin after progression on gemcitabine-based therapy.
Julie Fleshman, CEO of the Pancreatic Cancer Action Network, stated that Nalirifox represe...
