Drug · Small Molecule

Irinotecan

CI-DRUG-00000312Explore in graph →NCIt C62040 CHEMBL481 CIViC Approved

Regulatory

Approvals (28)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory9 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2024-02-13 (see label)	approved	Feb 13, 2024	openfda
US FDA	Pancreatic Adenocarcinoma	ONIVYDE is indicated, in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma. ONIVYDE is indicated, in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. Limitations of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic pancreatic adenocarcinoma. [see Clinical Studies (14) ] . ONIVYDE is a topoisomerase inhibitor indicated: in combination with oxaliplatin, fluorouracil and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma, ( 1 ) in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. ( 1 ) Limitation of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic pancreatic adenocarcinoma. ( 1 )

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 19 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	181	99	140	958	28	CA, EU, US	Jun 14, 1996	1995-11
Malignant Pancreatic Neoplasm	Approved	Phase 3	34	16	11	89	2	EU, US	Oct 22, 2015	1998-04
Malignant Colon Neoplasm	Approved	Phase 3	4	2	6	35	4	US	Jun 14, 1996	1999-05
Malignant Gastric Neoplasm	Phase4	Phase 4	16	11	12	73

Curated evidence

Clinical evidence (44)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–44 of 44 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
BRAF V600E6
Irinotecan + Panitumumab

Clinical trials

Trials with this intervention (963)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 101–150 of 963 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT00079274	Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer	completed	Phase 3	3,397	National Cancer Institute (NCI)NIH	3	Jun 23, 2026	clinicaltrials
NCT03872947	A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

Molecule

Record

Kind: Small Molecule
Mechanism: DNA topoisomerase I inhibitor
Targets: 1 gene
UNII: 042LAQ1IIS
Aliases: [1,4'-bipiperidine]-1'-carboxylic Acid (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl Ester, (+)-(4S)-4,11-diethyl-4-hydroxy-9-[(4-piperidino-piperidino)carbonyloxy]-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinol-3,14,(4H,12H)-dione, 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin, (+)-7-ethyl-10-hydroxycamptothecine 10-[1,4'-bipiperidine]-1'-carboxylate, Biotecan, CAMPTOSAR, Irinophore c, Irinotecan, IRINOTECAN HYDROCHLOIDE, Irinotecan Hydrochloride, IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE TRIHYDRATE, Irinotecan Sucrose Octasulfate, NSC-728073, ONIVYDE, Onivyde pegylated liposomal

Data updated 22 hours agoSource updated unknown

Identifiers

Codes (38)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01CE02	IRINOTECAN
DIN (Health Canada)

BRAF D594G2
Cetuximab + IrinotecanCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Does Not Support Resistance	3	accepted	EID2201 One patient participating in a large retrospective study of cetuximab in metastatic, treatment refractory colorectal cancer had a tumor which harbored BRAF D594G and was wildtype for KRAS, NRAS and PI… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID4472 In a retrospective study of 53, KRAS exon 2 wild-type, metastatic colorectal cancer patients, patients harboring BRAF G466A (n=1), G469A (n=2), D594G (n=1), or V600E (n=2) mutations were reported to b… (full text at CIViC) PMID 26989027 · Hsu et al., 2016 · Open in CIViC	civic

KRAS A146P2
Cetuximab + IrinotecanCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID2225 In a retrospective study of 68 irinotecan-refractory metastatic colorectal cancer patients, one patient's tumor harbored a KRAS codon 146 mutation but was wildtype for BRAF, and KRAS codons 12, 13, an… (full text at CIViC) PMID 19603018 · Loupakis et al., 2009 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	2	submitted	EID13017 In a retrospective study of patients with irinotecan-refractory metastatic colorectal cancer whose tumors were wild type for KRAS codons 12 and 13, one patient whose tumor harbored a KRAS A146 mutatio… (full text at CIViC) PMID 19603018 · Loupakis et al., 2009 · Open in CIViC	civic

KRAS Q61P2
Cetuximab + IrinotecanSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	3	submitted	EID7177 Mutations in KRAS are associated with resistance to monoclonal antibodies that target EGFR in patients with colorectal cancer. [KRAS codon 61 mutations occur in approximately 1 – 4% of colorectal canc… (full text at CIViC) PMID 21575616 · French et al., 2011 · Open in CIViC	civic
Irinotecan	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	—	submitted	EID2806 In colorectal cancer patients, non-G12/G13 KRAS and NRAS mutations were associated with improved disease-free survival (n=186, P=0.006) compared to G12 and G13 KRAS mutations. None of the 12 Stage I-… (full text at CIViC) PMID 20570890 · Janakiraman et al., 2010 · Open in CIViC	civic