Drugs / Crizotinib
last change Jul 2026 re-read 2 minutes ago

Crizotinib

also known as PF-02341066 · XALKORI · NSC-756645 · Pf-2341066

Small molecule targets ALK, MET, MST1R, ROS1 via inhibition

Developed for
non-small cell lung carcinoma · plasma cell myeloma · anaplastic large cell lymphoma · refractory malignant neoplasm · ALK-positive anaplastic large cell lymphoma · inflammatory myofibroblastic tumor · metastatic malignant neoplasm · adenocarcinoma
+44 more · adult lymphoma · colorectal cancer · uveal melanoma · breast cancer · cancer · cancer of unknown primary site · gallbladder cancer · lung adenocarcinoma · lung carcinoma · melanoma · neoplasm · neuroblastoma · papillary renal cell carcinoma · renal cell carcinoma · acoustic neuroma · ALK+ histiocytosis · alveolar rhabdomyosarcoma · alveolar soft part sarcoma · brain glioblastoma · castration-resistant prostate carcinoma · childhood acute myeloid leukemia · childhood malignant neoplasm · cholangiocarcinoma · clear cell sarcoma · cutaneous melanoma · diffuse intrinsic pontine glioma · endometrial cancer · extrahepatic bile duct carcinoma · glioblastoma · hematopoietic and lymphoid cell neoplasm · hepatocellular carcinoma · high grade malignant neoplasm · lung cancer · metastatic malignant neoplasm in the brain · NF2-related schwannomatosis · non-Hodgkin lymphoma · ureter neoplasm · urethra neoplasm · urinary bladder cancer · urinary bladder neoplasm · urothelial carcinoma · breast lobular carcinoma · gastric cancer · triple-negative breast carcinoma
Investigated by
Pfizer · National Cancer Institute (NCI) · Bristol-Myers Squibb · M.D. Anderson Cancer Center · AstraZeneca · Hunan Province Tumor Hospital
+112 more · Array BioPharma · Canadian Cancer Trials Group · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Children's Oncology Group · Chinese PLA General Hospital · Eastern Hepatobiliary Surgery Hospital · Hoffmann-La Roche · Huashan Hospital · IDEAYA Biosciences · Memorial Sloan Kettering Cancer Center · Merck Sharp & Dohme LLC · NRG Oncology · Oslo University Hospital · RenJi Hospital · Ruijin Hospital · Samsung Medical Center · Shanghai Jiao Tong University School of Medicine · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Air Force General Hospital of the PLA · Alacris · Amgen · Anhui Provincial Hospital · Astellas Pharma Inc · Astex Pharmaceuticals, Inc. · Augusta University · Bayer · Beaumont Hospital · Beijing Hospital · Belfast Health and Social Care Trust · Boehringer Ingelheim · Bryan Schneider, MD · Cancer Research UK · Charite University, Berlin, Germany · Chi Mei Medical Hospital · Children's Hospital of Philadelphia · Chinese Thoracic Oncology Group · Clovis Oncology - Pharma and · Columbia University · Dana-Farber Cancer Institute · Dutch Cancer Society · ECOG-ACRIN Cancer Research Group · Eisai Inc. · Eli Lilly and Company · European Commission · European Georges Pompidou Hospital · European Organisation for Research and Treatment of Cancer - EORTC · Experimental Cancer Medicine Centres · Federal Research Institute of Pediatric Hematology, Oncology and Immunology · First Hospitals affiliated to the China PLA General Hospital · Fondation ARC · Fondazione Ricerca Traslazionale · GlaxoSmithKline · Grupo Español de Investigación en Neurooncología · Guangdong Association of Clinical Trials · Harbin Medical University · Herlev and Gentofte Hospital · Hoosier Cancer Research Network · Hospital Vall d'Hebron · Incyte Corporation · Indiana University · Ipsen · Janssen, LP · Jean M. Tersak, M.D. · Jun Zhu · Kaohsiung Medical University · Kaohsiung Veterans General Hospital. · Massachusetts General Hospital · Max-Planck Institut · Mingzhi Zhang · Ministry of Health, Republic of Korea · Mirati Therapeutics Inc. · Mothaffar Rimawi · Nanchang University · National Cancer Institute, France · all 118 on the full record

Regulatory milestones approvals, filings & regulatory actions · 10 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (8) US (FDA) XALKORI 2013-11-20 – 2023-09-07 fda.gov
Approved EU (EMA) Xalkori 2012-10-23 europa.eu
Approved US (FDA) XALKORI 2011-08-26 fda.gov

Trials 101 · started per year

today
US approved 2011
EU approved 2012
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2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02277457 Sep 2015 → Jun 2021 non-small cell lung carcinoma University of Michigan Rogel Cancer Center Withdrawn No outcome recorded
Phase 133 trials
Phase 1 NCT04693468 Dec 2020 → Dec 2027 expected high grade malignant neoplasm, metastatic malignant neoplasm M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1 NCT03978143 Jun → Oct 2019 Pfizer Completed No outcome recorded
Phase 1 NCT03137134 Jun → Sep 2017 Pfizer Completed No outcome recorded
Phase 1 NCT02511184 Oct 2015 → Dec 2017 Pfizer Terminated No outcome recorded
Phase 1 NCT02510001 Nov 2014 → Dec 2018 colorectal cancer University of Oxford Completed No outcome recorded
Phase 1 NCT02270034 Aug 2014 → Oct 2020 brain glioblastoma Grupo Español de Investigación en Neurooncología Completed No outcome recorded
Phase 1 NCT02207504 Aug 2014 → Feb 2018 castration-resistant prostate carcinoma Dana-Farber Cancer Institute Completed No outcome recorded
Phase 1 NCT02074878 Jun 2014 → May 2017 breast cancer Mothaffar Rimawi Terminated No outcome recorded
Phase 1 NCT01999972 Feb 2014 → Feb 2017 Pfizer Completed No outcome recorded
Phase 1 NCT01998126 Dec 2013 → May 2017 non-small cell lung carcinoma University of Utah Completed No outcome recorded
Phase 1/26 trials
Phase 1/2 NCT04292119 May 2020 → Dec 2022 non-small cell lung carcinoma, refractory malignant neoplasm Massachusetts General Hospital Unknown No outcome recorded
Phase 1/2 NCT03947385 Jun 2019 → Jan 2027 expected colorectal cancer, cutaneous melanoma, uveal melanoma IDEAYA Biosciences Recruiting No outcome recorded
Phase 1/2 NCT02584634 Dec 2015 → Feb 2021 non-small cell lung carcinoma Pfizer Terminated No outcome recorded
Phase 1/2 NCT02574078 Nov 2015 → Apr 2020 non-small cell lung carcinoma Bristol-Myers Squibb Completed No outcome recorded
Phase 1/2 NCT01712217 Oct 2012 → Dec 2016 non-small cell lung carcinoma Astex Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1/2 NCT00939770 Sep 2009 → Dec 2018 anaplastic large cell lymphoma, neuroblastoma, refractory malignant neoplasm Children's Oncology Group Completed No outcome recorded
Phase 244 trials
Phase 2 NCT06563999 Nov 2024 → Nov 2027 expected lung carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT05725200 Sep 2022 → Dec 2038 expected colorectal cancer Oslo University Hospital Recruiting No outcome recorded
Phase 2 NCT05014464 Nov 2021 → Jun 2026 overdue non-small cell lung carcinoma Hunan Province Tumor Hospital Recruiting No outcome recorded
Phase 2 NCT04423185 Aug 2020 → Jul 2026 overdue Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting No outcome recorded
Phase 2 NCT04322890 Apr 2020 → Dec 2026 expected non-small cell lung carcinoma Hunan Province Tumor Hospital Recruiting No outcome recorded
Phase 2 NCT04322578 Mar 2020 → Mar 2025 non-small cell lung carcinoma Hunan Province Tumor Hospital Unknown No outcome recorded
Phase 2 NCT04644432 Mar 2020 → Sep 2022 renal cell carcinoma Herlev and Gentofte Hospital Unknown No outcome recorded
Phase 2 NCT04283669 Feb 2020 → Feb 2025 NF2-related schwannomatosis, acoustic neuroma University of Alabama at Birmingham Completed No outcome recorded
Phase 2 NCT04084717 Dec 2019 → Dec 2024 non-small cell lung carcinoma University Health Network, Toronto Completed No outcome recorded
Phase 2 NCT04193007 Dec 2019 → Dec 2021 metastatic malignant neoplasm in the brain, non-small cell lung carcinoma Second Affiliated Hospital of Nanchang University Unknown No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT05987332 Oct 2023 → Jan 2027 expected uveal melanoma IDEAYA Biosciences Active not recruiting No outcome recorded
Phase 2/3 NCT03874273 Feb 2019 → Feb 2021 inflammatory myofibroblastic tumor Federal Research Institute of Pediatric Hematology, Oncology and Immunology Unknown No outcome recorded
Phase 35 trials
Phase 3 NCT03194893 Jul 2017 → Sep 2025 neoplasm Hoffmann-La Roche Completed No outcome recorded
Phase 3 NCT02201992 Mar 2015 → May 2036 expected non-small cell lung carcinoma ECOG-ACRIN Cancer Research Group Active not recruiting No outcome recorded
Phase 3 NCT01639001 Sep 2012 → Jun 2015 non-small cell lung carcinoma Pfizer Completed No outcome recorded
Phase 3 NCT01154140 Jan 2011 → Nov 2013 non-small cell lung carcinoma Pfizer Completed No outcome recorded
Phase 3 NCT00932893 Sep 2009 → Mar 2012 non-small cell lung carcinoma Pfizer Completed No outcome recorded
Phase 44 trials
Phase 4 NCT05160922 Dec 2021 → Mar 2028 expected anaplastic large cell lymphoma, inflammatory myofibroblastic tumor, non-small cell lung carcinoma Pfizer Active not recruiting No outcome recorded
Phase 4 NCT03672643 Jan 2019 → Sep 2023 Pfizer Terminated No outcome recorded
Phase 4 NCT03707847 Oct 2018 → Feb 2020 ALK-positive anaplastic large cell lymphoma Mingzhi Zhang Unknown No outcome recorded
Phase 4 NCT02487316 Jul 2015 → Nov 2017 ALK-positive anaplastic large cell lymphoma Jun Zhu Withdrawn No outcome recorded
Phase not applicable3 trials
NCT05792644 Jan 2018 → May 2022 ALK+ histiocytosis Harbin Medical University Completed No outcome recorded
NCT05063058 Jan 2016 → Nov 2019 melanoma Charite University, Berlin, Germany Completed No outcome recorded
NCT02194738 Sep 2014 → Sep 2026 expected non-small cell lung carcinoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase not stated3 trials
NCT02824094 non-small cell lung carcinoma Pfizer No longer available No outcome recorded
NCT02473497 neoplasm Pfizer No longer available No outcome recorded
NCT03085186 inflammatory myofibroblastic tumor Jean M. Tersak, M.D. No longer available No outcome recorded
Also used as a comparator or background therapy in 19 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01125904 Background Jun 2010 Pfizer Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01970865 Background Jan 2014 → Mar 2017 non-small cell lung carcinoma Pfizer Completed No outcome recorded
Phase 21 trial
Phase 2 NCT03620643 Comparator May 2019 → Aug 2024 breast lobular carcinoma, gastric cancer, triple-negative breast carcinoma Royal Marsden NHS Foundation Trust Completed No outcome recorded
Phase 313 trials
Phase 3 NCT06564324 Comparator Nov 2024 → Jan 2029 expected non-small cell lung carcinoma Nuvation Bio Inc. Recruiting No outcome recorded
Phase 3 NCT06254599 Comparator May 2024 → May 2026 overdue non-small cell lung carcinoma Shouyao Holdings (Beijing) Co. LTD Not yet recruiting No outcome recorded
Phase 3 NCT06140836 Comparator Dec 2023 → Mar 2026 overdue non-small cell lung carcinoma Bristol-Myers Squibb Active not recruiting No outcome recorded
Phase 3 NCT06082635 Comparator Dec 2023 → Apr 2026 overdue non-small cell lung carcinoma Shenzhen TargetRx Co., Ltd. Active not recruiting No outcome recorded
Phase 3 NCT05204628 Comparator Feb 2022 → May 2025 non-small cell lung carcinoma Xuanzhu Biopharmaceutical Co., Ltd. Unknown No outcome recorded
Phase 41 trial
Phase 4 NCT04356118 Background Jun 2020 → Jun 2023 malignant leptomeningeal tumor Hui Bu Unknown No outcome recorded
Phase not applicable2 trials
NCT02701231 Background Nov 2015 → Dec 2020 lung cancer Chinese PLA General Hospital Unknown No outcome recorded
NCT00828919 Background Mar 2003 → Aug 2023 cancer Pfizer Completed No outcome recorded

Press releases naming this drug 14 releases

DateIssuerRelease
2021-01-14 Pfizer Pfizer’s XALKORI® (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults pfizer.com
2020-09-23 Pfizer FDA Accepts Supplemental New Drug Application for Pfizer’s XALKORI® (crizotinib) for the Treatment of Pediatric ALK-positive Anaplastic Large Cell Lymphoma pfizer.com
2018-05-29 Pfizer Pfizer’s XALKORI® (crizotinib) Receives FDA Breakthrough Therapy Designation in Two New Indications pfizer.com
2017-09-11 Pfizer Pfizer Presents Overall Survival Data of XALKORI in Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer pfizer.com
2017-06-05 Roche Global Development Phase III study showed Roche’s Alecensa (alectinib) reduced the risk of disease progression or death by more than half versus crizotinib as first-line treatment in a specific type of lung cancer roche.com
2017-04-10 Roche Global Development Phase III study shows Roche’s Alecensa was superior to crizotinib in a specific type of lung cancer roche.com
2016-08-31 Pfizer XALKORI® (Crizotinib) Receives Approval In European Union For The Treatment Of Patients With ROS1-Positive Advanced Non-Small Cell Lung Cancer pfizer.com
2016-03-11 Pfizer XALKORI® (crizotinib) Approved by U.S. FDA for the Treatment of Patients with ROS1-Positive Metastatic Non-Small Cell Lung Cancer pfizer.com
2015-12-08 Pfizer Pfizer Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for XALKORI® (crizotinib) for the Treatment of Patients with ROS1-Positive Metastatic Non-Small Cell Lung Cancer pfizer.com
2015-11-24 Pfizer Pfizer Receives European Approval to Expand Use of XALKORI® (crizotinib) to First-Line Treatment of Adults with ALK-Positive Advanced Non-Small Cell Lung Cancer pfizer.com
2015-11-18 Pfizer Pfizer Reports Positive Topline Results from Phase 3 Trial Comparing XALKORI® (crizotinib) to Chemotherapy in Previously Untreated East Asian Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) pfizer.com
2015-04-21 Pfizer Pfizer Receives U.S. FDA Breakthrough Therapy Designation For XALKORI® (crizotinib) For The Treatment Of Patients With ROS1-Positive Non-Small Cell Lung Cancer pfizer.com

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 121 sources stand behind the page.

FieldValueCited text
Known as crizotinib Crizotinib (Pfizer, CA, USA) is an oral small-molecule RTK inhibitor that targets ALK and MET, and potentially other RTKs.” PMID 22316363 Feb 2012
110

Crizotinib (Pfizer, CA, USA) is an oral small-molecule RTK inhibitor that targets ALK and MET, and potentially other RTKs.” PMID 22316363 Feb 2012

“if EGFR mutation is positive, (gefitinib, ecotinib, erlotinib)or ALK/ROS-1 positive(Crizotinib)” NCT04193007

“Single 250 mg crizotinib dose as coated microsphere 1 (cMS1) formulation will be administered” NCT03978143

“With sensitive result the first-line therapy will be Erlotinib/Gefitinib/Crizotinib.” NCT02701231

“MET Inhibitors (Crizotinib 250 mg 2/d, or Cabozantinib 60mg/d)” NCT05063058

“Arm B: Crizotinib monotherapy at 250 mg twice daily (BID)” NCT06564324

Crizotinib is a medication that is taken by mouth.” NCT02074878

“ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib” NCT04356118

Crizotinib 250 mg twice a day for 4 weeks” NCT04644432

“Clofarabine, Crizotinib, Cytarabine” NCT02788201

“Drug: Sorafenib Drug: CrizotinibNCT03768375

“12. MET: CrizotinibNCT02101385

“Drug: CrizotinibNCT02511184

CrizotinibNCT02142036

NCT02638428

NCT01531361

NCT06563999

NCT03874273

NCT03620643

NCT02034981

NCT03297606

NCT01822496

NCT05204628

NCT01419041

NCT05725200

NCT04439266

NCT01999972

NCT01121588

NCT02946359

NCT02465060

NCT01945021

NCT02270034

NCT04603807

NCT02207504

NCT02499614

NCT02664935

NCT01998126

NCT04439253

NCT04283669

NCT03947385

NCT02006277

NCT06254599

NCT04084717

NCT04009317

NCT02435108

NCT06140836

NCT05160922

NCT03574402

NCT04030429

NCT03088930

NCT01579994

NCT02183870

NCT00939770

NCT00828919

NCT03052608

NCT01441388

NCT02737501

NCT02419287

NCT06082635

NCT01548144

NCT02487316

NCT01125904

NCT02134912

NCT03085186

NCT01970865

NCT03194893

NCT04322578

NCT02925234

NCT06360575

NCT02574078

NCT02201992

NCT01744652

NCT02194738

NCT04423185

NCT05987332

NCT02075840

NCT06357975

NCT02836847

NCT01979536

NCT02584634

NCT05014464

NCT01147055

NCT02612194

NCT01639001

NCT01524926

NCT02838420

NCT02223819

NCT03137134

NCT04322890

NCT01606878

NCT02277457

NCT01149785

NCT03737994

NCT02824094

NCT04693468

NCT02761057

NCT01549574

NCT03707847

NCT01644773

NCT02473497

NCT04632758

NCT01297595

NCT01168934

NCT01500824

NCT01712217

NCT04292119

NCT01576406

NCT02767804

NCT05792644

NCT03672643

Known as NSC-756645 ChEMBL registry synonym — accepted as the source's own label CHEMBL601719
Known as PF-02341066 “A Phase 1, Fixed Sequence, Cross-Over Study To Estimate The Effect Of Multiple Dose Rifampin On The Single Dose Pharmacokinetics Of Crizotinib (PF-02341066) In Healthy Volunteers” NCT01147055
13

“A Phase 1, Single Dose, Randomized, Cross-Over Absolute Bioavailability Study In Healthy Volunteers Comparing Oral To Intravenous Administration Of Crizotinib (PF-02341066)” NCT01168934

“Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK)” NCT01121588

“Crizotinib (PF-02341066)” NCT01524926

NCT01121575

NCT00965731

NCT01082380

NCT02510001

NCT00939731

NCT00932893

NCT01250730

NCT01441128

NCT00932451

NCT00585195

Known as Pf-2341066 ChEMBL registry synonym — accepted as the source's own label CHEMBL601719
Known as XALKORI “Crizotinib (Xalkori (Registered)) Expanded Access Protocol For The Treatment Of Japanese Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or...” NCT02824094
2

“Crizotinib, also called XALKORI, is a chemotherapy drug that is currently approved for the treatment of ALK- or ROS1- positive advanced non-small cell lung cancer.” NCT04084717

“The marketing name of the drug is "Xalkori".” NCT02074878

Action Inhibit “Macrophage-stimulating protein receptor inhibitor” CHEMBL601719
1

“targets ALK and MET” PMID 22316363 Feb 2012

Modality Small molecule “Crizotinib (Pfizer, CA, USA) is an oral small-molecule RTK inhibitor” PMID 22316363 Feb 2012
Route Oral “PF-02341066 is taken by mouth daily.” NCT00585195
Target ALK “targets ALK and MET” PMID 22316363 Feb 2012
Target MET “targets ALK and METPMID 22316363 Feb 2012
Target MST1R “Macrophage-stimulating protein receptor inhibitor” CHEMBL601719