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Irinotecan wrapped in a fat bubble so it circulates longer. It is approved for pancreatic cancer, and in bile duct and gallbladder cancer one Korean trial found it helped as second-line treatment while a German trial did not.
Liposomal irinotecan is a nanoliposomal formulation of irinotecan that prolongs circulation of the active metabolite SN-38 and increases tumour exposure. It is approved for metastatic pancreatic adenocarcinoma after gemcitabine-based therapy (NAPOLI-1; United States 2015, European Union 2016) and, with oxaliplatin, fluorouracil and leucovorin (NALIRIFOX), as first-line treatment of metastatic pancreatic adenocarcinoma (NAPOLI 3; United States 2024). In biliary tract cancer it has no licence. The Korean NIFTY phase 2b trial randomised 174 patients who had progressed on gemcitabine and cisplatin to fluorouracil and leucovorin with or without liposomal irinotecan: blinded central review progression-free survival was 7.1 versus 1.4 months (hazard ratio 0.56) at the first analysis and 4.2 versus 1.7 months (hazard ratio 0.61) when the scans were re-read with extended follow-up, with grade 3 to 4 neutropenia in 24 percent versus 1 percent. The German NALIRICC trial (100 patients) found no benefit, and the earlier German NIFE trial compared it non-comparatively with gemcitabine and cisplatin in first line. NCCN lists it as an option after gemcitabine and cisplatin; in the UK it is not commissioned for biliary cancer, where FOLFOX (ABC-06) is the second-line standard. UGT1A1 poor metabolisers need dose reduction.
Liposomal delivery of irinotecan; SN-38 traps topoisomerase I and DNA in cleavage complexes.
1.Liposomal irinotecan slips into a pocket on its target.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
| Region | Year | Indication |
|---|---|---|
| US | 2015 | Metastatic pancreatic adenocarcinoma after gemcitabine-based therapy, with fluorouracil and leucovorin (NAPOLI-1) · FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8b58efa-1820-48a4-b70d-62918fc4abfc |
| EU | 2016 | Metastatic pancreatic adenocarcinoma after gemcitabine, with fluorouracil and leucovorin · EMA EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal |
| US | 2024 | First-line metastatic pancreatic adenocarcinoma in NALIRIFOX (NAPOLI 3) · FDA label (DailyMed) |
| UK | 2017 | Metastatic adenocarcinoma of the pancreas after gemcitabine-based therapy, with fluorouracil and leucovorin: NICE TA440 (26 April 2017) does not recommend it within its marketing authorisation; NICE NG85 1.9.9 restates the position · https://www.nice.org.uk/guidance/ta440 |
| EU | 2016 | Metastatic adenocarcinoma of the pancreas after gemcitabine-based therapy, with fluorouracil and leucovorin (marketing authorisation 14 October 2016, orphan designation 2011); the EMA product information now also lists first-line use with oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) · https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia (grade 3-4) NIFTY, liposomal irinotecan arm | - | 24% |
| Fatigue or asthenia (grade 3-4) NIFTY | - | 13% |
Rates read from the source. Blank cells mean the figure was not sourced, not that it is zero.
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The document that made biomarker testing part of routine pancreatic cancer care in the United States; the 2018 version it built on fixed the second-line chemotherapy sequence still used in most guidelines.
The first approved second-line regimen and the basis of NALIRIFOX, which NAPOLI 3 later moved to first line; it fixed the sequence (gemcitabine-based first, then liposomal irinotecan with fluorouracil) written into the 2018 ASCO guideline.
Query for this drug: (TITLE:"Liposomal irinotecan" OR ABSTRACT:"Liposomal irinotecan" OR TITLE:"Onivyde" OR ABSTRACT:"Onivyde" OR TITLE:"nal-IRI" OR ABSTRACT:"nal-IRI" OR TITLE:"MM-398" OR ABSTRACT:"MM-398" OR TITLE:"PEP02" OR ABSTRACT:"PEP02") 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 Liposomal irinotecan, not a curated reading list.
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, Servier, 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).
Shares NALIRICC (AIO), NIFTY, Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer.
Shares NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer, Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX, HR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer, HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer.
Shares NIFE (AIO-YMO HEP-0315), NALIRICC (AIO), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer.
Shares NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer, Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX, A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based, HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer.
Shares NAPOLI-1, Ipsen, Pancreatic ductal adenocarcinoma.
Shares HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer, Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Canc, Gallbladder cancer, Pancreatic ductal adenocarcinoma.