OnCo
drugsProductApproved2024🇪🇺🇬🇧🇦🇺

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.

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Irinotecan (liposomal in NALIRIFOX)
PubChem
Modality
Cytotoxic regimen
Mechanism
Liposomal irinotecan (prolonged SN-38 exposure) with oxaliplatin and 5-FU/leucovorin.
Brand / code
Onivyde regimen
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

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.

Not yet researchedSearch NICE
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.

Regulatory

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Approvals

RegionYearIndication
US2024First-line metastatic pancreatic adenocarcinoma

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
NALIRIFOX (liposomal irinotecan + oxaliplatin + 5-FU/LV)
intervention: NALIRIFOX (liposomal irinotecan
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend24 papers in the last 12 months+71% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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