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Click here for Xalkori® (crizotinib) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.


  • Multicentre, single-arm phase II study in ROS1+ advanced / metastatic NSCLC patients (N=30). 
  • Primary Endpoint: Investigator-assessed Objective Response Rate (ORR) (Response Evaluation Criteria in Solid Tumours, version 1.1.)
  • Key Secondary Endpoints: progression-free survival (PFS), overall survival, efficacy by independent radiologic review, safety, health-related quality of life, and molecular characterisation of tumour tissue

Study Results:

  • Investigator ORR: 70% (95% confidence interval [CI]: 51-85)
  • Median PFS: 20.0 months (95% CI: 10.1 – not reached)
  • Median follow-up was 20.6 months.
  • Treatment-related adverse events were documented in 33 of 34 patients (97%).

  1. XALKORI Summary of Product Characteristics.
  2. Michels S, Massutí B, Schildhaus HU, et al. Safety and efficacy of crizotinib in patients with advanced or metastatic ROS1-rearranged lung cancer (EUCROSS): a European phase II clinical trial. J Thorac Oncol. 2019;14(7):1266-76.
PP-XLK-GBR-1169. March 2021


XALKORI as a monotherapy is indicated for:1

  • 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)

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