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DosingSafetyClinical TrialsClinical TrialsXALKORI Clinical TrialsROS1+ NSCLC: PROFILE 1001ALK+ NSCLC: PROFILE 1014

Real World Evidence

Real World EvidenceReal World EvidenceSequential XALKORI® and Ceritinib in ALK+ NSCLCXALKORI® and Post-Progression Treatment in ALK+ NSCLC


The information on this website is based on data from adult patients with ALK (anaplastic lymphoma kinase)-positive / ROS 1-positive advanced NSCLC (non small cell lung cancer) treated with XALKORI®(crizotinib), produced in line with the XALKORI®(crizotinib) Summary of Product Characteristics. XALKORI® (crizotinib) Prescribing Information click here. Adverse event reporting information can be found at the bottom of the page.

Clinical TrialsThe efficacy and safety of XALKORI® have been evaluated in patients with advanced ALK-positive NSCLC, who had received no previous systemic treatment for advanced disease, (n=343)2 and ROS1-positive (ROS1+) advanced NSCLC (n=53) 1Click below to read more about the studies: ​​​​​​ PROFILE 1001 

A Phase 1, single-arm study evaluating the efficacy and safety of XALKORI® in patients with ROS1+ advanced NSCLC (n=53)1

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PROFILE 1014 

A Phase 3 study evaluating the efficacy and safety of XALKORI® vs. chemotherapy as first-line therapy for ALK+ advanced NSCLC (n=343)2

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Pooled Safety Data for XALKORI®

The safety of XALKORI® has been evaluated in 1,722 patients, including patients with ALK+ (n=1,669) advanced NSCLC and ROS1+ advanced NSCLC (n=53)3

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ALK: anaplastic lymphoma kinase, NSCLC: non-small cell lung cancer

ReferencesShaw AT, Riely GJ, Bang YJ, et al. Ann Oncol. 2019;30(7):1121-6.Solomon BJ, Mok T, Kim DW, et al. N Eng J Med. 2014;371(23):2167-77.XALKORI® Summary of Product Characteristics 
PP-XLK-IRL-0259 February 2024 Legal Category S1A Further Information is available on request

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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