{"entity":{"id":"nalirifox","kind":"drug","name":"NALIRIFOX (liposomal irinotecan + oxaliplatin + 5-FU/LV)","aka":[],"tldr":"NALIRIFOX is a version of FOLFIRINOX using a liposome-wrapped irinotecan, approved in 2024 as a first-line option for metastatic pancreatic cancer.","summary":"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.","status":"approved","asOf":"2026-09-06","links":[{"label":"OncLive: FDA approves NALIRIFOX","url":"https://www.onclive.com/view/fda-approves-frontline-nalirifox-for-metastatic-pancreatic-adenocarcinoma"},{"label":"Onivyde label (openFDA): NALIRIFOX indication and NAPOLI 3 results table","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ONIVYDE%22"},{"label":"NICE TA1052: pegylated liposomal irinotecan in combination for untreated metastatic pancreatic cancer, terminated appraisal (2 April 2025)","url":"https://www.nice.org.uk/guidance/terminated/ta1052"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors","platinum"],"targets":[],"drugs":[],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":["prodrug"],"trials":["napoli-3","rasolute-302"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK status: NICE's appraisal of NALIRIFOX (TA1052) was terminated on 2 April 2025 because the company made no evidence submission, and NG85 does not name it, so it is not routinely commissioned in England; NICE's other position on liposomal irinotecan is TA440 (second line, not recommended). NAPOLI 3 recruited at six UK sites (Guy's and St Thomas', the Royal Marsden, Imperial, the Christie, Nottingham City)."],"brand":"Onivyde regimen","modality":"Cytotoxic regimen","mechanism":"Liposomal irinotecan (prolonged SN-38 exposure) with oxaliplatin and 5-FU/leucovorin.","approvals":[{"region":"US","year":2024,"indication":"First-line metastatic pancreatic adenocarcinoma"},{"region":"EU","year":2016,"indication":"Onivyde 2L after gemcitabine (2016); NALIRIFOX label 2025"},{"region":"EU","year":2025,"indication":"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","note":"https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/nalirifox/","neighbours":{"cancer":[{"id":"pancreatic-adenosquamous-carcinoma","kind":"cancer","name":"Adenosquamous carcinoma of the pancreas","route":"/cancers/pancreatic-adenosquamous-carcinoma/"},{"id":"borderline-resectable-pdac","kind":"cancer","name":"Borderline resectable pancreatic ductal adenocarcinoma","route":"/cancers/borderline-resectable-pdac/"},{"id":"brca-palb2-pdac","kind":"cancer","name":"BRCA or PALB2-mutant pancreatic ductal adenocarcinoma","route":"/cancers/brca-palb2-pdac/"},{"id":"ipmn-associated-carcinoma","kind":"cancer","name":"Invasive carcinoma arising in an intraductal papillary mucinous neoplasm (IPMN-associated carcinoma)","route":"/cancers/ipmn-associated-carcinoma/"},{"id":"kras-g12c-pdac","kind":"cancer","name":"KRAS G12C-mutant pancreatic ductal adenocarcinoma","route":"/cancers/kras-g12c-pdac/"},{"id":"kras-wild-type-pdac","kind":"cancer","name":"KRAS wild-type pancreatic ductal adenocarcinoma","route":"/cancers/kras-wild-type-pdac/"},{"id":"locally-advanced-pdac","kind":"cancer","name":"Locally advanced unresectable pancreatic ductal adenocarcinoma","route":"/cancers/locally-advanced-pdac/"},{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"company":[{"id":"ipsen","kind":"company","name":"Ipsen","route":"/companies/ipsen/"}],"term":[{"id":"chemotherapy-side-effects-pancreatic","kind":"term","name":"Living with FOLFIRINOX, NALIRIFOX and gemcitabine with nab-paclitaxel","route":"/terms/chemotherapy-side-effects-pancreatic/"},{"id":"pancreatic-cancer-uk-drug-access","kind":"term","name":"Pancreatic cancer drugs in England: NICE appraisals and the Cancer Drugs Fund (September 2026)","route":"/terms/pancreatic-cancer-uk-drug-access/"},{"id":"prodrug","kind":"term","name":"Prodrug","route":"/terms/prodrug/"}],"trial":[{"id":"nct06483555","kind":"trial","name":"Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel","route":"/trials/nct06483555/"},{"id":"nct07827053","kind":"trial","name":"Clinical Study of Radiotherapy Combined With Adebrelimab and NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer","route":"/trials/nct07827053/"},{"id":"napoli-3","kind":"trial","name":"NAPOLI 3","route":"/trials/napoli-3/"},{"id":"nct06736717","kind":"trial","name":"Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer","route":"/trials/nct06736717/"},{"id":"rasolute-302","kind":"trial","name":"RASolute 302","route":"/trials/rasolute-302/"}],"paper":[{"id":"paper-napoli-1-nanoliposomal-irinotecan-lancet-2016","kind":"paper","name":"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","route":"/key-papers/paper-napoli-1-nanoliposomal-irinotecan-lancet-2016/"}],"roadmap":[{"id":"pancreatic-roadmap","kind":"roadmap","name":"Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question","route":"/roadmaps/pancreatic-roadmap/"}]}}