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Crizotinib

Generic Name
Crizotinib
Brand Names
Xalkori
Drug Type
Small Molecule
Chemical Formula
C21H22Cl2FN5O
CAS Number
877399-52-5
Unique Ingredient Identifier
53AH36668S

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.

Background

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

FDA Approved Products

Xalkori
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:50 mg in 1 1
Approved: 2023/09/08
NDC:0069-0507
Xalkori
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:150 mg in 1 1
Approved: 2023/09/08
NDC:0069-1500
Xalkori
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/09/08
NDC:0069-8141
Xalkori
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:250 mg in 1 1
Approved: 2023/09/08
NDC:0069-8140
Xalkori
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/09/08
NDC:0069-0251

Singapore Approved Products

Xalkori Capsules 250mg
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:CAPSULE
Strength:250 mg
Online:Yes
Approved: 2012/10/11
Approval:SIN14248P
Xalkori Capsules 200mg
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:CAPSULE
Strength:200 mg
Online:Yes
Approved: 2012/10/11
Approval:SIN14247P

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