Crizotinib

XALKORI as monotherapy is indicated for: • The first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) • The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) • The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC) • The treatment of paediatric patients (age ≥1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) • The treatment of paediatric patients (age ≥1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK)-positive unresectable inflammatory myofibroblastic tumour (IMT)

XALKORI (crizotinib) is indicated for • use as monotherapy in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). • use in patients with ROS1-positive locally advanced (not amenable to curative therapy) or metastatic NSCLC.

Efficacy in patients with ROS1-positive NSCLC was based on objective response rate (ORR) and Duration of Response (DR) in a single arm study with a limited number of patients (N=53) including 7 patients who are treatment naïve. Using a validated ALK or ROS1 assay, assessment for ALK-positive or ROS1-positive locally advanced or metastatic NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilized.

Improper assay performance can lead to unreliable test results (see 14 CLINICAL TRIALS). There are no data available demonstrating improvement in overall survival with XALKORI. 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

XALKORI as monotherapy is indicated for:  The first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)  The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)  The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC)  The treatment of paediatric patients (age ≥1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL)  The treatment of paediatric patients (age ≥1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK)-positive unresectable inflammatory myofibroblastic tumour (IMT)