Drug · Small Molecule

Crizotinib

CI-DRUG-00000165Explore in graph →NCIt C74061 CHEMBL601719 CIViC Approved

Regulatory

Approvals (17)

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

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Xalkori as monotherapy is indicated for: The first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with ROS1 positive advanced non small cell lung cancer (NSCLC) The treatment of paediatric patients (age 1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL) The treatment of paediatric patients (age 1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT)

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 2 days 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	27	11	21	90	17	CA, EU, US	Aug 26, 2011	Mar 7, 2003
Non-Hodgkin Lymphoma	Approved	Phase 4	7	1	0	15	4	US	Aug 26, 2011	Apr 19, 2006
Malignant Lung Neoplasm	Phase4	Phase 4	15	4	16	44	0	—	—	2009-09
Multiple Myeloma	Phase2	Phase 2	6	1	0	6	0	—

Curated evidence

Clinical evidence (267)

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

civicCuratedShowing 1–50 of 267 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
ALK Overexpression + MET OverexpressionMET ALK1

Clinical trials

Trials with this intervention (100)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 100 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
NCT02194738	Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)	active not recruiting	N/A	7,458	National Cancer Institute (NCI)NIH	3	Sep 23, 2026	clinicaltrials
NCT06140836	A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

Molecule

Record

Kind: Small Molecule
Mechanism: Hepatocyte growth factor receptor inhibitor; ALK tyrosine kinase receptor inhibitor; EML4-ALK inhibitor; NPM/ALK (Nucleophosmin/ALK tyrosine kinase receptor) inhibitor; Proto-oncogene tyrosine-protein kinase ROS inhibitor; Macrophage-stimulating protein receptor inhibitor
Targets: 6 genes
UNII: 53AH36668S
Aliases: 2-Pyridinamine, 3-((1R)-1-(2,6-Dichloro-3-Fluorophenyl)Ethoxy)-5-(1-(4-Piperidinyl)-1H-Pyrazol-4-yl)-, Alkixen, Crizocent, Crizotinib, MET Tyrosine Kinase Inhibitor PF-02341066, NSC-756645, PF 02341066, PF-02341066, PF02341066, PF-2341066, (R)-3-(1-(2,6-Dichloro-3-Fluorophenyl)Ethoxy)-5-(1-(Piperidin-4-Yl)-1h-Pyrazol-4-Yl)Pyridin-2-Amine, Xalkori, XALKORI

Data updated 22 hours agoSource updated unknown

Identifiers

Codes (6)

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

System	Code	Label
ATC (WHO)	L01ED01	CRIZOTINIB
DIN (Health Canada)	02384256

ALK Fusion2
Crizotinib	Anaplastic Large Cell Lymphoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID1241 In the second part of this Phase I study NCT00939770, nine patients between the ages of 12 months and 22 years with anaplastic large cell lymphoma (ALCL), who were refractory to treatment and for whom… (full text at CIViC) PMID 23598171 · Mossé et al., 2013 · Open in CIViC	civic
〃	Anaplastic Large Cell Lymphoma	Predictive	D	Supports Sensitivity Response	5	accepted	EID1239 NPM-ALK in anaplastic large cell lymphoma (ALCL) was the first ALK-fusion to be discovered and characterized. In this study, targeted activity against NPM-ALK by the ALK and MET inhibitor crizotinib … (full text at CIViC) PMID 18089725 · Christensen et al., 2007 · Open in CIViC	civic

ALK Fusion11
Crizotinib	Anaplastic Large Cell Lymphoma	Predictive	A	Supports Sensitivity Response	4	accepted	EID11218 This trial enrolled 26 patients with anaplastic large cell lymphoma (ALCL). The groups received twice daily crizotinib at doses of either 165 or 280 mg/m2. 83% of the 165 mg/m2 ALCL patients had a com… (full text at CIViC) PMID 28787259 · Mossé et al., 2017 · Open in CIViC	civic
〃	Anaplastic Large Cell Lymphoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID7361 In this phase I/II study, 26 patients with relapsed/refractory ALK-positive ALCL were administered crizotinib orally twice daily in 28-day cycles as a single agent for an indefinite duration. Patients… (full text at CIViC) PMID 28787259 · Mossé et al., 2017 · Open in CIViC	civic
〃	Anaplastic Large Cell Lymphoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID11404 17 patients with ALK-positive advanced anaplastic large‐cell lymphoma (ALCL) enrolled in the PROFILE 1013 (NCT01121588) phase 1b single-arm, open-label, multi-centre study received crizotinib. ORR was… (full text at CIViC) PMID 29352732 · Gambacorti-Passerini et al., 2018 · Open in CIViC	civic
〃	Anaplastic Large Cell Lymphoma	Predictive	C	Supports Sensitivity Response	4	accepted	EID1240 Crizotinib at 250mg daily was given to two patients with relapsed ALK-rearranged anaplastic large cell lymphoma (ALCL). Patient one, 26 yrs old, had been treated with the CHOP-15 chemotherapy regimen,… (full text at CIViC) PMID 21345110 · Gambacorti-Passerini et al., 2011 · Open in CIViC	civic
〃	Anaplastic Large Cell Lymphoma	Predictive	C	Supports Sensitivity Response	3	rejected	EID1242 Four adult ALK-rearranged anaplastic large cell lymphoma (ALCL) patients were resistant to chemotherapy after 3 or more lines of treatment. The patients were administered 250 mg crizotinib twice dail… (full text at CIViC) PMID 23006951 · Foyil et al., 2012 · Open in CIViC	civic
〃	Anaplastic Large Cell Lymphoma	Predictive	D	Supports Sensitivity Response	3	submitted	EID7144 Authors report the ALK inactivation in ALK-positive ALCL induces an increase in BCL2 levels, which could contribute to therapeutic failures of current ALK targeted therapies. Their data strongly sugge… (full text at CIViC) PMID 30679328 · Torossian et al., 2019 · Open in CIViC	civic
〃	Colorectal Adenocarcinoma	Predictive	E	Supports Sensitivity Response	1	accepted	EID1334 26 colorectal adenocarcinoma samples were run on Affymetrix human Exon 1.0 arrays and a computational method that assessed differential 5' and 3' gene expression for each gene was used to find potenti… (full text at CIViC) PMID 19737969 · Lin et al., 2009 · Open in CIViC	civic
〃	Diffuse Large B-Cell LymphomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	accepted	EID1264 A 27 year old female patient with advanced-stage IV, CD20 negative diffuse large B cell lymphoma (DLBCL). ALK rearrangement was determined by FISH, but the ALK fusion partner was not determined due to… (full text at CIViC) PMID 24330038 · Wass et al., 2014 · Open in CIViC	civic
〃	Inflammatory Myofibroblastic Tumor	Predictive	A	Supports Sensitivity Response	3	accepted	EID11122 9 patients with ALK-positive inflammatory myofibroblastic tumour (IMT) enrolled in the PROFILE 1013 (NCT01121588) phase 1b single-arm, open-label, multi-centre study received crizotinib. ORR was 67% f… (full text at CIViC) PMID 29352732 · Gambacorti-Passerini et al., 2018 · Open in CIViC	civic
〃	Inflammatory Myofibroblastic Tumor	Predictive	B	Supports Sensitivity Response	3	accepted	EID1243 As part of a phase 1 dose-escalation trial (NCT00939770), seven patients between ages 12 months and 22 years with relapsed or refractory inflammatory myofibroblastic tumors with ALK-rearrangement were… (full text at CIViC) PMID 23598171 · Mossé et al., 2013 · Open in CIViC	civic
〃	Inflammatory Myofibroblastic Tumor	Predictive	B	Supports Sensitivity Response	3	accepted	EID7362 In this phase I/II study, 14 patients with metastatic or inoperable ALK-positive IMT were administered crizotinib orally twice daily in 28-day cycles as a single agent for an indefinite duration. The … (full text at CIViC) PMID 28787259 · Mossé et al., 2017 · Open in CIViC	civic

MET Amplification2
Crizotinib	GlioblastomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID1565 A 62 year old female was diagnosed with glioblastoma (GBM) WHO grade 4. Treatment included radiation, temozolomide and cediranib. MET amplification was found by FISH, and ALK and MET inhibitor crizoti… (full text at CIViC) PMID 22162573 · Chi et al., 2012 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID836 Case report of a patient with MET amplification without high-level MET/CEP7 ratio, MET exon 14 mutation or overexpression who achieved rapid response to crizotinib. PMID 26724472 · Zhang et al., 2016 · Open in CIViC	civic

ALK C1156Y + ALK Fusion2
Crizotinib	Lung Adenocarcinoma	Predictive	C	Supports Resistance	4	accepted	EID236 A 28 year-old patient with T4N3M1 stage lung adenocarcinoma harboring an EML4-ALK variant 1 fusion was treated with crizotinib after failing conventional therapy. The patient achieved a partial respon… (full text at CIViC) PMID 20979473 · Choi et al., 2010 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	C	Supports Resistance	2	accepted	EID4046 In a lung adenocarcinoma cancer patient with an EML4-ALK gene rearrangement (a known sensitizing alteration to crizotinib) and an ALK C1156Y co-mutation, ALK C1156Y was reported to be refractory to cr… (full text at CIViC) PMID 27045755 · Saber et al., 2016 · Open in CIViC	civic

ALK L1196M + ALK Fusion3
Crizotinib	Lung Adenocarcinoma	Predictive	C	Supports Resistance	4	accepted	EID237 A 28 year-old patient with non-small cell lung cancer was found to harbor the EML4-ALK (E13;A20) fusion using reverse transcription PCR. Treatment with 250mg crizotinib twice daily resulted in rapid i… (full text at CIViC) PMID 20979473 · Choi et al., 2010 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	C	Supports Resistance	2	submitted	EID4040 In a stage IV Hodgkin's lymphoma patient with metastatic lung adenocarcinoma harboring an EML4-ALK gene rearrangement (a known sensitizing alteration to crizotinib) and an ALK L1196M�co-mutation, ALK … (full text at CIViC) PMID 27507192 · Zhang et al., 2017 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	D	Supports Resistance	2	submitted	EID4039 In an in vitro study, a H3122 cell line expressing L1196M mutation in the ALK portion of the EML4-ALK fusion protein was associated with resistance to crizotinib treatment, as compared to H3122 cells … (full text at CIViC) PMID 27565908 · Lucena-Araujo et al., 2016 · Open in CIViC	civic