Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA
- Approval based on Phase III NAPOLI 3 clinical trial in which Onivyde® regimen (NALIRIFOX) demonstrated statistically significant superiority and clinically meaningful improvements in overall survival and progression-free survival versus nab-paclitaxel and gemcitabine
- NAPOLI 3 represents the first positive Phase III trial in first-line metastatic pancreatic adenocarcinoma (mPDAC) to demonstrate superior overall survival versus the currently approved regimen of nab-paclitaxel and gemcitabine
- Onivyde is the only FDA-approved treatment regimen to demonstrate efficacy in two Phase III trials across lines of therapy in mPDAC
PARIS, FRANCE, 13 February 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.
“The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen,” said Christelle Huguet, EVP and Head of Research and Development, Ipsen. “With today’s approval, this Onivyde (NALIRIFOX) regimen can now offer a potential new standard-of-care treatment option with proven survival benefits for people living with metastatic pancreatic adenocarcinoma in the U.S.”
Pancreatic adenocarcinoma (PDAC) is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally. Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV). Characterized as a complex cancer due to rapid tumor progression, limited genetic targets and multiple resistance mechanisms, mPDAC has a poor prognosis with fewer than 20% of people surviving longer than one year. Overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S... Ipsen's Press Release -
