Xalkori

(Crizotinib)

ApprovedSmall molecule

Crizotinib is used to treat certain types of lung cancer, specifically those with specific genetic mutations (ALK or ROS1 changes) that make the cancer cells sensitive to this drug.[2] Xalkori is currently approved and in use across 21 indications[4].[1]

Xalkori is one of 521 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Approved.

Indications

109

Total Trials

Active Trials

520

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Non-Small Cell Lung CancerCompleted

Glioblastoma MultiformeApproved

NF2-Related SchwannomatosisApproved

Inflammatory Myofibroblastic TumorApproved

Gastric CancerApproved

Uveal MelanomaActive, not recruiting

Kidney DiseaseApproved

Lung Signet Ring Cell CarcinomaActive, not recruiting

TreatmentActive, not recruiting

Advanced LymphomaActive, not recruiting

Non-Small Cell Lung CancerPhase 3

Completed

Glioblastoma MultiformeApproved

Approved

NF2-Related SchwannomatosisApproved

Approved

Inflammatory Myofibroblastic TumorApproved

Approved

Gastric CancerApproved

Approved

Uveal MelanomaPhase 3

Active, not recruiting

Kidney DiseaseApproved

Approved

Lung Signet Ring Cell CarcinomaPreclinical

Active, not recruiting

TreatmentPhase 2

Active, not recruiting

Advanced LymphomaPhase 2

Active, not recruiting

Showing 10 of 21 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Xalkori

PPrism Pharmaceuticals

Approved

26 2

SKB264

SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Phase 3

5 3

SI-B001

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

2 4

HS-20093

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Phase 3

1 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 10

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

PreclinicalActive, not recruiting

Lung Non-Small Cell Carcinoma

NCT02194738

Q4 2026

Phase 2Active, not recruiting

Treatment

NCT06360575

Phase 2Active, not recruiting

Treatment

NCT06357975

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Q1 2027

Phase 2Recruiting

Trial

NCT03297606

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT03737994

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer26 trials

Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)

Unknown status· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 3·NCT04009317·260 enrolled

A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients

Recruiting·NNuvation Bio Inc.·Phase 3·NCT06564324·138 enrolled

Real World Study on First Line Crizotinib in ROS1 Rearranged Advanced Non-squamous Non-small Cell Lung Cancer

Unknown status·HHunan Province Tumor Hospital··NCT03646994·40 enrolled

Show 23 more trials

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)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06140836·190 enrolled

A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT02574078·341 enrolled

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

Terminated· Pfizer logo

Pfizer·Phase 1·NCT01121588·44 enrolled

National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer

Active, not recruiting·UUniversity of Birmingham·Phase 2·NCT02664935·423 enrolled

A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients

Completed· Pfizer logo

Pfizer·Phase 3·NCT01639001·207 enrolled

Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

Active, not recruiting·EECOG-ACRIN Cancer Research Group·Phase 3·NCT02201992·166 enrolled

A Clinical Study Testing The Safety And Efficacy Of Crizotinib In East Asian Patients With Anaplastic Lymphoma Kinase (ALK) Positive Advanced Non-Small Cell Lung Cancer

Withdrawn· Pfizer logo

Pfizer·Phase 2·NCT01500824

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

Completed· Roche logo

Roche·Phase 3·NCT02075840·303 enrolled

A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib

Completed·AAstex Pharmaceuticals, Inc.·Phase 1/2·NCT01712217·220 enrolled

S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib

Terminated·SSWOG Cancer Research Network·Phase 2·NCT02134912·1 enrolled

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants

Completed·AAriad Pharmaceuticals·Phase 3·NCT02737501·275 enrolled

TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)

Active, not recruiting·SShenzhen TargetRx Co., Ltd.·Phase 3·NCT06082635·321 enrolled

Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Unknown status· Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.·Phase 3·NCT04632758·292 enrolled

Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03737994·10 enrolled

Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01822496·59 enrolled

Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer

Completed·UUniversity of Colorado, Denver·Phase 2·NCT03088930·3 enrolled

Real World Study of First Line Crizotinib for ALK Rearranged Non-squamous Non-small Cell Lung Cancer

Unknown status·HHunan Province Tumor Hospital··NCT03647111·120 enrolled

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

Completed· Pfizer logo

Pfizer··NCT05834348·5,279 enrolled

eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Active, not recruiting·XXcovery Holdings, Inc.·Phase 3·NCT02767804·290 enrolled

Combination Checkpoint Inhibitor Plus Erlotinib or Crizotinib for EGFR or ALK Mutated Stage IV Non-small Cell Lung Cancer

Completed·UUniversity of Utah·Phase 1·NCT01998126·14 enrolled

Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation

Recruiting·HHunan Province Tumor Hospital·Phase 2·NCT04322890·6,000 enrolled

Personalized Adaptive Radiation Therapy With Individualized Systemic Targeted Therapy (PARTIST) for Locally Advanced, Non-small Cell Lung Cancer With Genomic Driver Mutations

Withdrawn·UUniversity of Michigan Rogel Cancer Center·Phase 1·NCT02277457

XALKORI ROS1+NSCLC DRUG USE INVESTIGATION

Completed· Pfizer logo

Pfizer··NCT03375242·97 enrolled

Treatment5 trials

Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06360575·20 enrolled

Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes (MATCH - Subprotocol C1)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06357975·44 enrolled

Treatment With Crizotinib Single Patient Expanded Access IND 134375

No longer available·—··NCT03085186

Show 2 more trials

Testing Crizotinib as a Potential Targeted Treatment in Cancers With ALK Genetic Changes (MATCH-Subprotocol F)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04439266·5 enrolled

A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

Not yet recruiting·SShouyao Holdings (Beijing) Co. LTD·Phase 3·NCT06254599·255 enrolled

Anaplastic Large Cell Lymphoma4 trials

Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma

Completed·CChildren's Oncology Group·Phase 1/2·NCT00939770·122 enrolled

A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib

Withdrawn·JJun Zhu·Phase 4·NCT02487316

Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01979536·137 enrolled

Show 1 more trial

Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma

Completed·CChildren's Oncology Group·Phase 1·NCT01606878·46 enrolled

Uveal Melanoma3 trials

IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

Active, not recruiting·IIDEAYA Biosciences·Phase 2/3·NCT05987332·420 enrolled

Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy

Completed·—·Phase 2·NCT02223819·34 enrolled

A Randomized, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma

Recruiting·IIDEAYA Biosciences·Phase 3·NCT07804186·450 enrolled

Tics3 trials

Estimation Of Effect Of Rifampin On Pharmacokinetics Of Crizotinib In Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT01147055·15 enrolled

Estimation Of Effect Of Ketoconazole On Pharmacokinetics Of Crizotinib In Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT01149785·15 enrolled

A Study to Evaluate the Effects of Food and Esomeprazole on the Pharmacokinetics of Crizotinib in a Coated Microsphere Formulation.

Completed· Pfizer logo

Pfizer·Phase 1·NCT03137134·18 enrolled

54 more indications

Small Cell Lung Cancer3 trials

Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients

Terminated· Pfizer logo

Pfizer·Phase 1·NCT02511184·9 enrolled

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

Completed· Pfizer logo

Pfizer·Phase 1/2·NCT01970865·364 enrolled

Study to IDEntify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS)

Completed· Pfizer logo

Pfizer··NCT02679170·692 enrolled

Lung Cancer3 trials

Lorlatinib Combinations in Lung Cancer

Unknown status·MMassachusetts General Hospital·Phase 1/2·NCT04292119·96 enrolled

EUCROSS: European Trial on Crizotinib in ROS1 Translocated Lung Cancer

Completed·UUniversity of Cologne·Phase 2·NCT02183870·34 enrolled

Crizotinib in Pretreated Metastatic Non-small-cell Lung Cancer With MET Amplification or ROS1 Translocation (METROS)

Unknown status·FFondazione Ricerca Traslazionale·Phase 2·NCT02499614·80 enrolled

Efficacy and Safety2 trials

A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib

Unknown status·XXuanzhu Biopharmaceutical Co., Ltd.·Phase 3·NCT05204628·238 enrolled

Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1

Completed·UUNICANCER·Phase 2·NCT02034981·246 enrolled

Patients With Advanced Solid Tumors2 trials

A Study Of Crizotinib Plus VEGF Inhibitor Combinations In Patients With Advanced Solid Tumors.

Withdrawn· Pfizer logo

Pfizer·Phase 1·NCT01441388

A Phase 1b Study Of Axitinib In Combination With Crizotinib In Patients With Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT01999972·50 enrolled

Breast Cancer2 trials

CRIZENT: Crizotinib and Sunitinib in Metastatic Breast Cancer

Terminated·MMothaffar Rimawi·Phase 1·NCT02074878·3 enrolled

Crizotinib in Lobular Breast, Diffuse Gastric and Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours

Completed·RRoyal Marsden NHS Foundation Trust·Phase 2·NCT03620643·33 enrolled

Lymphoma2 trials

Pilot Study of Crizotinib in Relapsed ALK+ Lymphomas

Completed·UUniversity of Milano Bicocca·Phase 2·NCT02419287·12 enrolled

A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

Active, not recruiting· Roche logo

Roche·Phase 3·NCT03194893·200 enrolled

NSCLC2 trials

Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

Terminated· Pfizer logo

Pfizer·Phase 4·NCT03672643·41 enrolled

Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC

No longer available· Pfizer logo

Pfizer··NCT02824094

Trial2 trials

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

Recruiting·CCanadian Cancer Trials Group·Phase 2·NCT03297606·720 enrolled

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Advanced Cancer2 trials

Dasatinib and Crizotinib in Advanced Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01744652·62 enrolled

Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT01548144·178 enrolled

Safety and Efficacy2 trials

Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

Completed· Pfizer logo

Pfizer·Phase 2·NCT01945021·129 enrolled

Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)

Completed· Pfizer logo

Pfizer··NCT01597258·2,029 enrolled

Oral2 trials

Relative Bioavailability Of A Crizotinib Oral Liquid Formulation To Crizotinib Formulated Capsule

Completed· Pfizer logo

Pfizer·Phase 1·NCT01297595·22 enrolled

A Study To Taste Three New Types Of Crizotinib Formulation In Comparison Of An Oral Solution And To Measure The Amount Of Crizotinib In The Body After These Formulations Are Orally Given, Relative To Capsule Formulation

Completed· Pfizer logo

Pfizer·Phase 1·NCT02006277·21 enrolled

Advanced Lymphoma2 trials

MATCH Treatment Subprotocol G: Phase II Study of Crizotinib in Patients With ROS1 Translocations (Other Than Patients With Non-Small Cell Lung Cancer)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04439253·4 enrolled

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

Glioblastoma1 trial

Study to Evaluate Safety and Activity of Crizotinib With Temozolomide and Radiotherapy in Newly Diagnosed Glioblastoma

Completed·GGrupo Español de Investigación en Neurooncología·Phase 1·NCT02270034·38 enrolled

Prostate Cancer1 trial

Crizotinib in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer

Completed·—·Phase 1·NCT02207504·24 enrolled

Lorlatinib1 trial

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT03052608·296 enrolled

Interaction1 trial

Drug Drug Interaction Study Of Crizotinib With Esomeprazole.

Completed· Pfizer logo

Pfizer·Phase 1·NCT01549574·16 enrolled

Phase 11 trial

A Phase 1 Absolute Bioavailability Study For Oral Crizotinib In Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT01168934·14 enrolled

Impaired Renal Function1 trial

A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function

Completed· Pfizer logo

Pfizer·Phase 1·NCT01419041·16 enrolled

Advanced Malignancies1 trial

Vemurafenib With Sorafenib Tosylate or Crizotinib in Treating Patients With Advanced Malignancies With BRAF Mutations

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01531361·46 enrolled

Efficacy1 trial

Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)

Terminated· Pfizer logo

Pfizer·Phase 1/2·NCT02584634·43 enrolled

Refractory1 trial

Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory ALK+ ALCL

Unknown status·MMingzhi Zhang·Phase 4·NCT03707847·20 enrolled

MPA1 trial

Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT01154218·36 enrolled

Gallbladder Carcinoma1 trial

Molecularly Target Therapy With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 2·NCT02836847·152 enrolled

Squamous Cell Carcinoma1 trial

ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma

Recruiting·HHunan Province Tumor Hospital·Phase 2·NCT05014464·90 enrolled

Phase II1 trial

Phase II Umbrella Study Directed by Next Generation Sequencing

Unknown status·GGuangdong Association of Clinical Trials·Phase 2·NCT03574402·400 enrolled

Lung Adenocarcinoma1 trial

A+C in Metastatic Lung Adenocarcinoma Cancer

Unknown status·—·Phase 2·NCT02946359·60 enrolled

ALK1 trial

Therapeutic Effect of Crizotinib for Rearrangement-negative, High Phosphorylated ALK Patients

Completed·HHarbin Medical University·N/A·NCT05792644·15 enrolled

Tyrosine Kinase Inhibitor1 trial

Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.

Completed· Pfizer logo

Pfizer··NCT04647110·549 enrolled

Gastric Adenocarcinoma1 trial

A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy

Completed·SSamsung Medical Center·Phase 2·NCT02435108·2 enrolled

Relapsed or Refractory1 trial

Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy

Unknown status·SSamsung Medical Center·Phase 2·NCT02638428·90 enrolled

Glioma1 trial

Study of the Combination of Crizotinib and Dasatinib in Pediatric Research Participants With Diffuse Pontine Glioma (DIPG) and High-Grade Glioma (HGG)

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT01644773·36 enrolled

Unresectable1 trial

Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

Recruiting·SSun Yat-sen University·Phase 2·NCT06563999·120 enrolled

Metastatic Urothelial Cancer1 trial

LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer

Terminated·WWake Forest University Health Sciences·Phase 2·NCT02612194·8 enrolled

Pediatric Patients1 trial

Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients

No longer available· Pfizer logo

Pfizer··NCT02473497

Metastatic Colorectal Cancer1 trial

Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer

Recruiting·OOslo University Hospital·Phase 2·NCT05725200·40 enrolled

TED1 trial

Bioequivalence Study for Crizotinib Encapsulated Microsphere Formulation (eMS)

Completed· Pfizer logo

Pfizer·Phase 1·NCT04856293·25 enrolled

Adolescent1 trial

Study of Crizotinib in Children and Adolescents With Myofibroblastic Tumors

Unknown status·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology·Phase 2/3·NCT03874273·25 enrolled

Patients With Solid Tumors1 trial

Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

Recruiting·IIDEAYA Biosciences·Phase 1/2·NCT03947385·336 enrolled

Advanced NSCLC1 trial

Crizotinb or Standard Chemotherapy in Met Exon 14 Skipping Advanced NSCLC

Recruiting·HHunan Province Tumor Hospital·Phase 2·NCT04322578·120 enrolled

Kidney Cancer1 trial

Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02761057·152 enrolled

Clinical Trial1 trial

Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials

Completed· Pfizer logo

Pfizer·N/A·NCT00828919·52 enrolled

Adult1 trial

A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT01125904·5 enrolled

Hepatic Impairment1 trial

Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients

Completed· Pfizer logo

Pfizer·Phase 1·NCT01576406·88 enrolled

Vestibular schwannoma1 trial

Phase 2 Clinical Trial of Crizotinib for Children and Adults With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT04283669·12 enrolled

Rare Tumor1 trial

PLATFORM Study of Precision Medicine for Rare Tumors

Recruiting·—·Phase 2·NCT04423185·770 enrolled

Phase 21 trial

CREATE: Cross-tumoral Phase 2 With Crizotinib

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT01524926·582 enrolled

Endometrial Cancer1 trial

Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer

Terminated·NNational Cheng-Kung University Hospital·Phase 2·NCT04030429·40 enrolled

Advanced Malignant Solid Neoplasm1 trial

Modular Phase 1B Hypothesis-Testing, Biomarker-Driven, Talazoparib Combination Trial (TalaCom)

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04693468·111 enrolled

NSCLC (Advanced Non-small Cell Lung Cancer)1 trial

A Randomized, Open-Label, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of JYP0322 Versus Crizotinib in Previously Untreated ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Not yet recruiting·GGuangzhou JOYO Pharma Co., Ltd·Phase 3·NCT07816380·216 enrolled

Lung Non-Small Cell Carcinoma1 trial

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT02194738·8,300 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

Randomized, Open Label, Multicenter, Phase III Study of Entrectinib Versus Crizotinib in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring ROS1 Gene Rearrangements With and Without Central Nervous System Metastases

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04603807·217 enrolled

Non-Small Cell Lung Carcinoma1 trial

Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Asian Patients With Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

Completed· Roche logo

Roche·Phase 3·NCT02838420·187 enrolled

Non-Squamous Non-Small Cell Lung Cancer1 trial

Phase II Study of Crizotinib for ROS1 and MET Activated Lung Cancer (CROME)

Completed·UUniversity Health Network, Toronto·Phase 2·NCT04084717·33 enrolled

Unspecified1 trial

Crizotinib Continuation Clinical Study

Active, not recruiting· Pfizer logo

Pfizer·Phase 4·NCT05160922·27 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 26, 2011

XALKORI

NDA NDA202570

Sep 7, 2023

XALKORI

NDA NDA217581

Sources

References

[1]
ClinicalTrials.gov — 109 trial records for Crizotinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Xalkori drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Crizotinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Crizotinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA217581). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Xalkori. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Prism Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: EML4-ALK Inhibitor; NPM/ALK (nucleophosmin/alk Tyrosine Kinase Receptor) Inhibitor; ALK Tyrosine Kinase Receptor Inhibitor; Hepatocyte Growth Factor Receptor Inhibitor; Macrophage-Stimulating Protein Receptor Inhibitor; Proto-Oncogene Tyrosine-Protein Kinase ROS Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPrism Pharmaceuticals

Patent Landscape[6]

Patent Cliff

May 12, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7825137May 12, 2027

7858643Oct 8, 2029

8217057Nov 6, 2029

Xalkori

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer26 trials

Treatment5 trials

Anaplastic Large Cell Lymphoma4 trials

Uveal Melanoma3 trials

Tics3 trials

Small Cell Lung Cancer3 trials

Lung Cancer3 trials

Efficacy and Safety2 trials

Patients With Advanced Solid Tumors2 trials

Breast Cancer2 trials

Lymphoma2 trials

NSCLC2 trials

Trial2 trials

Advanced Cancer2 trials

Safety and Efficacy2 trials

Oral2 trials

Advanced Lymphoma2 trials

Glioblastoma1 trial

Prostate Cancer1 trial

Lorlatinib1 trial

Interaction1 trial

Phase 11 trial

Impaired Renal Function1 trial

Advanced Malignancies1 trial

Efficacy1 trial

Refractory1 trial

MPA1 trial

Gallbladder Carcinoma1 trial

Squamous Cell Carcinoma1 trial

Phase II1 trial

Lung Adenocarcinoma1 trial

ALK1 trial

Tyrosine Kinase Inhibitor1 trial

Gastric Adenocarcinoma1 trial

Relapsed or Refractory1 trial

Glioma1 trial

Unresectable1 trial

Metastatic Urothelial Cancer1 trial

Pediatric Patients1 trial

Metastatic Colorectal Cancer1 trial

TED1 trial

Adolescent1 trial

Patients With Solid Tumors1 trial

Advanced NSCLC1 trial

Kidney Cancer1 trial

Clinical Trial1 trial

Adult1 trial

Hepatic Impairment1 trial

Vestibular schwannoma1 trial

Rare Tumor1 trial

Phase 21 trial

Endometrial Cancer1 trial

Advanced Malignant Solid Neoplasm1 trial

NSCLC (Advanced Non-small Cell Lung Cancer)1 trial

Lung Non-Small Cell Carcinoma1 trial

Carcinoma, Non-Small-Cell Lung1 trial

Non-Small Cell Lung Carcinoma1 trial

Non-Squamous Non-Small Cell Lung Cancer1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

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