Overview
Crizotinib is a tyrosine kinase receptor inhibitor used for the treatment of anaplastic lymphoma kinase (ALK) or ROS1-positive non-small cell lung cancer (NSCLC) tumors, as well as ALK-positive anaplastic large cell lymphoma (ALCL) and inflammatory myofibroblastic tumor (IMT). By targeting the echinoderm microtubule-associated protein-like 4 (EML4)-ALK fusion protein, crizotinib offers robust effectiveness in treating NSCLC in patients with this type of rearrangement. Crizotinib was the first-in-class drug used to treat ALK-positive tumors. Second- and third-generation ALK-tyrosine kinase-inhibitors have overcome many of the pharmacodynamic and genetic resistance mechanisms crizotinib is prone to. Crizotinib was approved by the FDA in 2011, and its use is accompanied by FDA-approved tests used to detect ALK and ROS1 rearrangements.
Indication
Crizotinib is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. Crizotinib is also indicated for the treatment of relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive in pediatric patients 1 year of age and older and young adults. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. Additionally, crizotinib is indicated for the treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.
Associated Conditions
- Metastatic Non-Small Cell Lung Cancer
- Refractory Anaplastic Large Cell Lymphoma
- Recurrent Inflammatory Myofibroblastic Tumors
- Refractory Inflammatory Myofibroblastic Tumors
- Relapsed Anaplastic Large Cell Lymphoma
- Unresectable Inflammatory Myofibroblastic Tumors
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/21 | Phase 2 | Recruiting | Sun Yat-sen University | ||
2024/08/21 | Phase 3 | Recruiting | |||
2024/04/11 | Phase 2 | Active, not recruiting | |||
2024/04/10 | Phase 2 | Active, not recruiting | |||
2024/02/12 | Phase 3 | Not yet recruiting | Shouyao Holdings (Beijing) Co. LTD | ||
2023/11/20 | Phase 3 | Recruiting | |||
2023/10/13 | Phase 3 | Active, not recruiting | |||
2023/08/14 | Phase 2 | Recruiting | |||
2023/04/28 | N/A | Completed | |||
2023/03/31 | Not Applicable | Completed | Harbin Medical University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc | 0069-0507 | ORAL | 50 mg in 1 1 | 9/8/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-1500 | ORAL | 150 mg in 1 1 | 9/8/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-8141 | ORAL | 200 mg in 1 1 | 9/8/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-8140 | ORAL | 250 mg in 1 1 | 9/8/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0251 | ORAL | 20 mg in 1 1 | 9/8/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 10/23/2012 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Xalkori Capsules 250mg | SIN14248P | CAPSULE | 250 mg | 10/11/2012 | |
| Xalkori Capsules 200mg | SIN14247P | CAPSULE | 200 mg | 10/11/2012 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| XALKORI crizotinib 200 mg capsule blister pack | 190964 | Medicine | A | 9/27/2013 | |
| XALKORI crizotinib 250 mg capsule blister pack | 190965 | Medicine | A | 9/27/2013 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| XALKORI 250 MG CAPSULAS DURAS | 112793003 | CÁPSULA DURA | Diagnóstico Hospitalario | Commercialized | |
| XALKORI 200 MG CAPSULAS DURAS | 112793001 | CÁPSULA DURA | Diagnóstico Hospitalario | Commercialized | |
| XALKORI 20 MG GRANULADO EN CAPSULAS PARA ABRIR | 112793005 | GRANULADO EN CAPSULAS PARA ABRIR | Diagnóstico Hospitalario | Commercialized | |
| XALKORI 150 MG GRANULADO EN CAPSULAS PARA ABRIR | 112793007 | GRANULADO EN CAPSULAS PARA ABRIR | Diagnóstico Hospitalario | Commercialized | |
| XALKORI 50 MG GRANULADO EN CAPSULAS PARA ABRIR | 112793006 | GRANULADO EN CAPSULAS PARA ABRIR | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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