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 20 indications[4].[1]
Xalkori is one of 483 small molecule programs targeting Lung Signet Ring Cell Carcinoma. It is currently in Approved.
20
Indications
109
Total Trials
30
Active Trials
482
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
3
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 20 indications
Competition
Competitive Landscape
414 competitors in Non-Small Cell Lung Cancer
#DrugCompanyPhaseTrials
1Xalkori
PPrism Pharmaceuticals
Approved
Yervoy
Bristol-Myers SquibbPhase 3
Tuoyi
SSun Yat-sen University
Phase 3
Second-Line Systemic Therapy
SSun Yat-sen University
Phase 3
Remeron
OOrganon and Co
Preclinical
Aqupla
Jiangsu Simcere Pharmaceutical Co., Ltd.Preclinical
Ftorafur
TThe First Affiliated Hospital with Nanjing Medical University
Preclinical
Vibramycin
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
Treatment
GSKPreclinical
PD-1 Inhibitors
BBioNTech US Inc.
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Non-Small Cell Lung Cancer25 trials
Show 22 more trials
Anaplastic Large Cell Lymphoma4 trials
Show 1 more trial
Treatment4 trials
Show 1 more trial
Treatment With Crizotinib Single Patient Expanded Access IND 134375
No longer available·—··NCT03085186
Tics3 trials
55 more indications
Small Cell Lung Cancer3 trials
Uveal Melanoma3 trials
Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy
Completed·—·Phase 2·NCT02223819·34 enrolled
Advanced Lymphoma3 trials
Patients With Advanced Solid Tumors2 trials
Breast Cancer2 trials
Efficacy and Safety2 trials
Trial2 trials
Oral2 trials
NSCLC2 trials
Safety and Efficacy2 trials
Advanced Cancer2 trials
Carcinoma, Non-Small-Cell Lung2 trials
Lung Adenocarcinoma1 trial
A+C in Metastatic Lung Adenocarcinoma Cancer
Unknown status·—·Phase 2·NCT02946359·60 enrolled
ALK1 trial
Prostate Cancer1 trial
Crizotinib in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Completed·—·Phase 1·NCT02207504·24 enrolled
Adult1 trial
MPA1 trial
Gallbladder Carcinoma1 trial
Squamous Cell Carcinoma1 trial
Glioblastoma1 trial
Tyrosine Kinase Inhibitor1 trial
Lorlatinib1 trial
Impaired Renal Function1 trial
Vestibular schwannoma1 trial
Gastric Adenocarcinoma1 trial
Advanced Malignancies1 trial
Efficacy1 trial
Refractory1 trial
Relapsed or Refractory1 trial
Glioma1 trial
Unresectable1 trial
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
Metastatic Urothelial Cancer1 trial
Pediatric Patients1 trial
Metastatic Colorectal Cancer1 trial
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
Kidney Cancer1 trial
Clinical Trial1 trial
Lung Non-Small Cell Carcinoma1 trial
Neoplasms1 trial
Advanced Malignant Solid Neoplasm1 trial
Non-Squamous Non-Small Cell Lung Cancer1 trial
Unspecified1 trial
Regulatory
FDA Approval Timeline[5]
Aug 26, 2011
XALKORI
NDA NDA202570
Sep 7, 2023
XALKORI
NDA NDA217581
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Xalkori drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Crizotinib. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
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