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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.
Converted by carboxylesterases to SN-38, which traps topoisomerase I-DNA cleavage complexes; UGT1A1*28 slows SN-38 clearance and raises toxicity.
1.Irinotecan (and liposomal irinotecan) slips into a pocket on its target.
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.
Multi-source generic; covered under the medical benefit without prior authorisation in most plans, as part of standard regimens. Onivyde usually requires prior authorisation.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA93 · SMC advice: irinotecan. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Metastatic colon or rectal carcinoma that progressed following 5-FU therapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Metastatic colon or rectal carcinoma that progressed following 5-FU therapy
Confirmed: the accelerated approval of 1996 converted to traditional approval 2.4 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 1996 | Metastatic colorectal cancer after 5-FU; first line with 5-FU/LV 2000 |
| US | 2015 | Liposomal irinotecan with 5-FU/LV in metastatic pancreatic cancer after gemcitabine |
| US | 2024 | Liposomal irinotecan in NALIRIFOX first-line metastatic pancreatic cancer |
Check interactions for Irinotecan (and liposomal irinotecan) →
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A positive randomised phase 2 that the German NALIRICC trial failed to reproduce; guidelines list the regimen as an option, and the disagreement is a reminder that single-country phase 2 results in biliary cancer need replication.
The second total neoadjuvant therapy schedule to change practice, and the one that shows the advantage is partly deliverability: chemotherapy given before an operation is completed by far more patients than chemotherapy given after one.
Confirms irinotecan-temozolomide-dinutuximab as the reference salvage regimen and motivated frontline chemo-immunotherapy trials (ANBL17P1, ANBL1531).
Encorafenib with cetuximab became the standard second-line treatment for BRAF V600E disease, and the platform BREAKWATER later moved into first line with chemotherapy added, doubling survival again.
Chemo-immunotherapy with dinutuximab became the salvage standard for relapsed neuroblastoma and the regimen to move into first-line induction.
The triplet is the option for fit patients who need a response, particularly in BRAF-mutant and right-sided disease where the EGFR antibody route is closed; it also quantified how much worse BRAF-mutant disease was before BEACON and BREAKWATER.
Together with PARADIGM it makes the EGFR antibody the preferred first partner for chemotherapy in left-sided RAS wild-type disease; the survival gain without a progression-free survival gain remains one of the field's unexplained results.
FOLFIRINOX and, soon after, gemcitabine plus nab-paclitaxel ended the era of single-agent gemcitabine for metastatic pancreatic cancer. The regimen's modified form later improved survival after surgery in PRODIGE 24, and its toxicity is why fitness, not just stage, decides which treatment a patient is offered.
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.
Shares A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan, Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer, FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM, G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer and the tags generic, who-essential.
Shares FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM, Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or Irinotecan in Patients With Advanced Gastric Cancer, Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial, PROPHYLOCHIP-PRODIGE 15 and the tags generic, who-essential.
Shares FOXO1 fusion status and IRS group (rhabdomyosarcoma), High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN), Hepatoblastoma, Group 3 and group 4 medulloblastoma (non-WNT/non-SHH) and the tags generic, who-essential.
Shares FOXO1 fusion status and IRS group (rhabdomyosarcoma), Rhabdomyosarcoma, Ewing sarcoma, Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs and the tags generic, who-essential.
Shares FOXO1 fusion status and IRS group (rhabdomyosarcoma), Group 3 and group 4 medulloblastoma (non-WNT/non-SHH), Rhabdomyosarcoma, High-risk neuroblastoma and the tags generic, who-essential.
Shares AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2, A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors, Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer, PRODIGE 4 / ACCORD 11 and the tags generic, who-essential.
Shares DNA replication & origin licensing, Group 3 and group 4 medulloblastoma (non-WNT/non-SHH), Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs, Medulloblastoma and the tags generic, who-essential.
Shares High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN), Rhabdomyosarcoma, High-risk neuroblastoma, Ewing sarcoma and the tags generic, who-essential.