Ipsen (EPA: IPN, OTCMKTS: IPSEY), the France-based biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for the NALIRIFOX regimen, which combines Onivyde (irinotecan liposome injection) with oxaliplatin, fluorouracil, and leucovorin. This new approval allows for the use of the regimen as a first-line treatment for metastatic pancreatic adenocarcinoma (mPDAC).
This marks the second FDA approval for the Onivyde regimen in the context of mPDAC, following the initial approval in 2015 for its use with fluorouracil and leucovorin in the second-line treatment after progression on gemcitabine-based therapies. Pancreatic ductal adenocarcinoma is the most prevalent form of pancreatic cancer, with over 60,000 new cases diagnosed annually in the U.S. and nearly 500,000 globally. The FDA’s decision was informed by results from the NAPOLI 3 randomized, open-label, Phase III trial, which involved 770 patients with mPDAC across 18 countries. The trial achieved both primary and secondary endpoints, demonstrating that the NALIRIFOX regimen significantly improved median overall survival (mOS) to 11.1 months (95% confidence interval) compared to 9.2 months (95% CI) for nab-paclitaxel and gemcitabine.- Flcube.com
