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Irinotecan (and liposomal irinotecan)

Irinotecan is a topoisomerase-blocking chemotherapy central to bowel and pancreatic cancer regimens (FOLFIRI, FOLFIRINOX, NALIRIFOX) and to salvage therapy in childhood sarcomas; it carries the same warhead as the deruxtecan ADC payloads.

Approved 1996 (colorectal after 5-FU); FOLFIRI first line with bevacizumab/cetuximab; FOLFIRINOX (2011) and liposomal irinotecan (NAPOLI-1 2015, NAPOLI-3 NALIRIFOX 2024) in pancreatic cancer; irinotecan-temozolomide in Ewing, rhabdomyosarcoma, neuroblastoma; vincristine-irinotecan windows in RMS. Diarrhoea (cholinergic and delayed) and neutropenia; UGT1A1 genotyping is label-recommended.

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Irinotecan
PubChem
Modality
Topoisomerase I inhibitor (camptothecin prodrug)
Mechanism
Converted by carboxylesterases to SN-38, which traps topoisomerase I-DNA cleavage complexes; UGT1A1*28 slows SN-38 clearance and raises toxicity.
Brand / code
Camptosar / Onivyde
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. Generic irinotecan; liposomal irinotecan (Onivyde) is a branded Part B drug that plans may review.

Commercial insurance
covered on label

Multi-source generic; covered under the medical benefit without prior authorisation in most plans, as part of standard regimens. Onivyde usually requires prior authorisation.

Assistance programmes

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

NICE recommendedNICE TA93 · 2005SMC: accepted
Appraised for
Irinotecan, oxaliplatin and raltitrexed for advanced colorectal cancer
Notes
Generic; funded routinely. Liposomal irinotecan (Onivyde) with 5-FU for pancreatic cancer after gemcitabine was appraised in TA440 (2017).
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA93 · SMC advice: irinotecan. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US1996Metastatic colorectal cancer after 5-FU; first line with 5-FU/LV 2000
US2015Liposomal irinotecan with 5-FU/LV in metastatic pancreatic cancer after gemcitabine
US2024Liposomal irinotecan in NALIRIFOX first-line metastatic pancreatic cancer

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
1626 studies10 recruiting82 Phase 221 Phase 3
Search “Irinotecan” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Irinotecan (and liposomal irinotecan)
intervention: Irinotecan
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Irinotecan" OR ABSTRACT:"Irinotecan" OR TITLE:"and liposomal irinotecan" OR ABSTRACT:"and liposomal irinotecan" OR TITLE:"Camptosar" OR ABSTRACT:"Camptosar" OR TITLE:"Onivyde" OR ABSTRACT:"Onivyde") 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 Irinotecan (and liposomal irinotecan), not a curated reading list.

Connected

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