NALIRIFOX (liposomal irinotecan + oxaliplatin + 5-FU/LV)
NALIRIFOX is a version of FOLFIRINOX using a liposome-wrapped irinotecan, approved in 2024 as a first-line option for metastatic pancreatic cancer.
NAPOLI 3 (n=770): OS 11.1 vs 9.2 months (HR 0.84) and PFS 7.4 vs 5.6 months versus gemcitabine plus nab-paclitaxel. FDA approval February 2024. Ipsen. The first phase 3 head-to-head win between the two chemotherapy backbones, though the absolute gain is modest.
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Ipsen Cares
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Notes
- EU-licensed 2024 for first-line metastatic pancreatic cancer; NICE appraisal 2025. Check NICE.
Sources: NICE search: NALIRIFOX (liposomal irinotecan regimen). Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2024 | First-line metastatic pancreatic adenocarcinoma |
Trials
topRecruiting now (live from ClinicalTrials.gov)
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Landmark trials in OnCo
Latest papers
topQuery 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.