Crizotinib: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Crizotinib appears in the FDA drug-label database. Marketed as Xalkori.

Drug class

Kinase Inhibitor (FDA established pharmacologic class)

Mechanism of action

Cytochrome P450 3A Inhibitors; Receptor Tyrosine Kinase Inhibitors; Cytochrome P450 2B6 Inhibitors; P-Glycoprotein Inhibitors; Organic Cation Transporter 1 Inhibitors; Organic Cation Transporter 2 Inhibitors (as stated on the FDA label)

FDA-approved use

XALKORI is a kinase inhibitor indicated for the treatment of • adult 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. ( 1.1 , 2.1 ) • pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. ( 1.2 , 2.3 ) o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. ( 1.3 , 2.3 ) 1.1 ALK- or ROS1-Positive Metastatic Non-Small Cell Lung Cancer XALKORI is indicated for the treatment of adult 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 [see Dosage and Administration (2.1) ] . 1.2 Relapsed or Refractory, Systemic ALK-Positive Anaplastic Large Cell Lymphoma XALKORI is indicated for the treatment of pediatri…

FDA label via openFDA