Ipsen (Euronext: IPN; ADR: IPSEY) has announced the approval by the U.S. Food and Drug Administration (FDA) of the supplemental new drug application for Onivyde® (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) as a first-line therapy for adults with metastatic pancreatic adenocarcinoma (mPDAC). This approval marks the second endorsement for an Onivyde regimen in mPDAC, following the FDA’s initial approval in 2015 of Onivyde in combination with fluorouracil and leucovorin after disease progression with gemcitabine-based therapy.
Christelle Huguet, EVP and Head of Research and Development at Ipsen, stated, “The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma compared to the currently approved nab-paclitaxel and gemcitabine regimen.” With this approval, the Onivyde (NALIRIFOX) regimen presents a potential new standard-of-care option with proven survival benefits for individuals with metastatic pancreatic adenocarcinoma in the United States.
Pancreatic adenocarcinoma (PDAC) is the most prevalent type of pancreatic cancer, with over 60,000 diagnoses annually in the U.S. and nearly 500,000 globally. Due to its often-late detection and rapid progression to metastatic or stage IV disease, PDAC has a poor prognosis, with less than 20% of individuals surviving beyond one year. As one of the most challenging cancers to manage, the approval of new treatment options represents significant progress in improving patient outcomes.
Dr. Zev Wainberg, Professor of Medicine and Co-Director of the UCLA GI Oncology Program, emphasized the importance of this approval, stating, “The approval of this Onivyde regimen is an important milestone for people living with mPDAC, their families and healthcare providers.” He noted that the NAPOLI 3 trial demonstrated survival benefits compared to current standard-of-care options.
Julie Fleshman, JD, MBA, President and CEO of Pancreatic Cancer Action Network (PanCAN), expressed gratitude for the patients who participated in the clinical trial, recognizing their role in advancing pancreatic cancer treatments.
The FDA approval was based on data from the NAPOLI 3 trial, a Phase III pivotal trial involving 770 individuals with mPDAC. Results showed that the NALIRIFOX regimen significantly improved median overall survival (mOS) and progression-free survival (mPFS) compared to nab-paclitaxel and gemcitabine. The safety profile of the Onivyde regimen was manageable, with the most common Grade 3/4 adverse events being diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation, and decreased weight.
The National Comprehensive Cancer Network® (NCCN) guidelines have recognized NALIRIFOX as a preferred treatment option in first-line metastatic and locally advanced disease.
