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NALIRIFOX is a version of FOLFIRINOX using a liposome-wrapped irinotecan, approved in 2024 as a first-line option for metastatic pancreatic cancer.
NALIRIFOX combines liposomal irinotecan, which gives prolonged exposure to the active metabolite SN-38, with oxaliplatin and 5-FU/leucovorin; it is a version of FOLFIRINOX built around the liposome-wrapped drug. It is a first-line option for metastatic pancreatic adenocarcinoma in patients fit enough for a multi-drug regimen. NAPOLI 3 (n=770) showed overall survival of 11.1 versus 9.2 months (HR 0.84) and PFS of 7.4 versus 5.6 months against gemcitabine plus nab-paclitaxel, and the FDA approved it in February 2024 (Ipsen). It was the first phase 3 head-to-head win between the two chemotherapy backbones, though the absolute gain is modest and critics note the absence of a modified FOLFIRINOX arm, so whether it beats conventional FOLFIRINOX is unknown. For a newcomer, it is four-drug pancreatic chemotherapy with a longer-acting irinotecan.
Liposomal irinotecan (prolonged SN-38 exposure) with oxaliplatin and 5-FU/leucovorin.
1.NALIRIFOX (liposomal irinotecan + oxaliplatin + 5-FU/LV) slips into a pocket on its target.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Each component is billed separately; liposomal irinotecan (Onivyde) is the branded, reviewed component.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. Plans compare NALIRIFOX against FOLFIRINOX and may require justification.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA1052. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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| Region | Year | Indication |
|---|---|---|
| US | 2024 | First-line metastatic pancreatic adenocarcinoma |
| EU | 2016 | Onivyde 2L after gemcitabine (2016); NALIRIFOX label 2025 |
| EU | 2025 | First-line treatment of metastatic adenocarcinoma of the pancreas (Onivyde pegylated liposomal with oxaliplatin, fluorouracil and leucovorin), listed in the EMA therapeutic indications read on 24 September 2026; the year is the corpus's regional row for the label extension · https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal |
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Query for this drug: (TITLE:"NALIRIFOX" OR ABSTRACT:"NALIRIFOX" OR TITLE:"liposomal irinotecan + oxaliplatin + 5-FU/LV" OR ABSTRACT:"liposomal irinotecan + oxaliplatin + 5-FU/LV" OR TITLE:"Onivyde regimen" OR ABSTRACT:"Onivyde regimen") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about NALIRIFOX (liposomal irinotecan + oxaliplatin + 5-FU/LV), not a curated reading list.
Shares NAPOLI 3, RASolute 302, Pancreatic cancer drugs in England: NICE appraisals and the Cancer Drugs Fund (September 2026), Ipsen.
Shares RASolute 302, KRAS G12C-mutant pancreatic ductal adenocarcinoma, BRCA or PALB2-mutant pancreatic ductal adenocarcinoma, Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question.
Shares Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial, NAPOLI 3, RASolute 302, Pancreatic cancer drugs in England: NICE appraisals and the Cancer Drugs Fund (September 2026).
Shares Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial, Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Topoisomerase-I inhibitors (and ADC payloads), Metastatic pancreatic ductal adenocarcinoma.
Shares RASolute 302, Locally advanced unresectable pancreatic ductal adenocarcinoma, Metastatic pancreatic ductal adenocarcinoma, Platinum agents.
Shares Living with FOLFIRINOX, NALIRIFOX and gemcitabine with nab-paclitaxel, Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel, Adenosquamous carcinoma of the pancreas, NAPOLI 3.
Shares Living with FOLFIRINOX, NALIRIFOX and gemcitabine with nab-paclitaxel, Adenosquamous carcinoma of the pancreas, NAPOLI 3, Pancreatic cancer drugs in England: NICE appraisals and the Cancer Drugs Fund (September 2026).
Shares KRAS G12C-mutant pancreatic ductal adenocarcinoma, KRAS wild-type pancreatic ductal adenocarcinoma, BRCA or PALB2-mutant pancreatic ductal adenocarcinoma, Borderline resectable pancreatic ductal adenocarcinoma.