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

XALKORI (crizotinib)

An established treatment option for your ROS1+ and ALK+ advanced NSCLC patients.


Dosing and monitoring requirements for XALKORI

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Clinical trial results including efficacy and safety outcomes

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Important safety information

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XALKORI (crizotinib)

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).

Test patients with advanced NSCLC for ROS1, in accordance with international guidelines2-4

As a distinct molecular target in NSCLC5, ROS1 should be a reflex biomarker test alongside EGFR and ALK​​​​​​​.2,3 XALKORI offers a potential median OS>4 years in ROS1+ advanced NSCLC patients, as demonstrated in the PROFILE 1001 study.6​​​​​​​

Video Resources

KOL video resources, including best practices for ROS1 testing, tissue sample acquisition and the optimal model for molecular testing in patients with ROS1.

Video Resources

  1. XALKORI Summary of Product Characteristics
  2. Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018;142(3):321-46.
  3. Planchard D, Popat S, Kerr K, et al. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Updated version published 15 September 2020 by the ESMO guidelines committee. Available at: Accessed March 2020.
  4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Non-Small Cell Lung Cancer V.2.2020. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed February 5, 2020. To view the most recent and complete version of the guideline, go online to NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  5. Bubendorf L, Büttner R, Al-Dayel F, et al. Testing for ROS1 in non-small cell lung cancer: a review with recommendations. Virchows Arch. 2016;469(5):489-503.
  6. Shaw AT, Riely GJ, Bang YJ, et al. Crizotinib in ROS1-rearranged advanced non-small cell lung cancer (NSCLC):updated results,including overall survival,from PROFILE 1001. Ann Oncol. 2019;30(7):1121-6.

PP-XLK-GBR-1162. March 2021

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PP-PFE-GBR-2688. December 2020