Crizotinib

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
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.	2024/08/21	NCT06563999	Phase 2	Recruiting	Sun Yat-sen University
A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients	2024/08/21	NCT06564324	Phase 3	Recruiting	Nuvation Bio Inc.
Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2)	2024/04/11	NCT06360575	Phase 2	Active, not recruiting	National Cancer Institute (NCI)
Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes (MATCH - Subprotocol C1)	2024/04/10	NCT06357975	Phase 2	Active, not recruiting	National Cancer Institute (NCI)
A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC	2024/02/12	NCT06254599	Phase 3	Not yet recruiting	Shouyao Holdings (Beijing) Co. LTD
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)	2023/11/20	NCT06140836	Phase 3	Recruiting	Bristol-Myers Squibb
TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)	2023/10/13	NCT06082635	Phase 3	Active, not recruiting	Shenzhen TargetRx, Inc.
IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma	2023/08/14	NCT05987332	Phase 2	Recruiting	IDEAYA Biosciences
A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.	2023/04/28	NCT05834348	N/A	Completed	Pfizer
Therapeutic Effect of Crizotinib for Rearrangement-negative, High Phosphorylated ALK Patients	2023/03/31	NCT05792644	Not Applicable	Completed	Harbin Medical University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Xalkori	Pfizer Laboratories Div Pfizer Inc	0069-0507	ORAL	50 mg in 1 1	9/8/2023
Xalkori	Pfizer Laboratories Div Pfizer Inc	0069-1500	ORAL	150 mg in 1 1	9/8/2023
Xalkori	Pfizer Laboratories Div Pfizer Inc	0069-8141	ORAL	200 mg in 1 1	9/8/2023
Xalkori	Pfizer Laboratories Div Pfizer Inc	0069-8140	ORAL	250 mg in 1 1	9/8/2023
Xalkori	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
Xalkori	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	10/23/2012

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Xalkori Capsules 250mg	Pfizer Manufacturing Deutschland GmbH	SIN14248P	CAPSULE	250 mg	10/11/2012
Xalkori Capsules 200mg	Pfizer Manufacturing Deutschland GmbH	SIN14247P	CAPSULE	200 mg	10/11/2012

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Crizotinib Capsules	Pfizer Europe MA EEIG	国药准字HJ20171014	化学药品	胶囊剂	2/10/2022
Crizotinib Capsules	Pfizer Europe MA EEIG	国药准字HJ20171012	化学药品	胶囊剂	2/10/2022
Crizotinib Capsules	Pfizer Europe MA EEIG	国药准字HJ20171008	化学药品	胶囊剂	2/10/2022
Crizotinib Capsules	Pfizer Europe MA EEIG	国药准字HJ20171009	化学药品	胶囊剂	2/10/2022
Crizotinib Capsules	复星万邦（江苏）医药集团有限公司	国药准字H20234492	化学药品	胶囊剂	11/21/2023
Crizotinib Capsules	复星万邦（江苏）医药集团有限公司	国药准字H20234491	化学药品	胶囊剂	11/21/2023
Crizotinib Capsules	Pfizer Europe MA EEIG	国药准字HJ20171011	化学药品	胶囊剂	2/10/2022
Crizotinib Capsules	Pfizer Europe MA EEIG	国药准字HJ20171013	化学药品	胶囊剂	2/10/2022

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	Pfizer Australia Pty Ltd	Medicine	A	9/27/2013
XALKORI crizotinib 250 mg capsule blister pack	190965	Pfizer Australia Pty Ltd	Medicine	A	9/27/2013

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