What is the role of crizotinib (Xalkori) in the treatment of non–small cell lung cancer (NSCLC)?

Updated: Jul 15, 2021
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
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Crizotinib (Xalkori) was approved by the FDA in August 2011 for the treatment of locally advanced or metastatic NSCLC that is ALK positive, as detected by the Vysis ALK Break Apart FISH Probe test (Abbott Molecular). Approval was based on 2 multicenter trials (n=255) in which median response duration ranged from 41.9-48.1 weeks. [178, 179]

In a study of patients with previously treated advanced NSCLC who had ALK gene rearrangement, treatment with crizotinib was superior to standard chemotherapy. [180] Risk of progression was reduced by 50% with crizotinib. Study participants with locally advanced or metastatic ALK-positive lung cancer treated with one previous platinum-based regimen were randomized to oral crizotinib 250 mg twice daily or to chemotherapy with intravenous pemetrexed (500 mg/m²) or docetaxel (75 mg/m²) every 3 weeks. As part of a separate analysis, patients in the chemotherapy group with disease progression were allowed to cross over to crizotinib. [180]

Median progression-free survival was longer with crizotinib treatment (7.7 mo) than with chemotherapy (3.0 mo). The hazard ratio for progression or death with crizotinib was 0.49 (95% confidence interval [CI], 0.37-0.64; P < 0.001), and the response rate was higher in the crizotinib group (65%) than in the chemotherapy group (20%) (P < 0.001). Overall survival was similar in the two groups. [180]

In March 2016 the FDA expanded use of crizotinib to include patients with metastatic NSCLC whose tumors harbor a ROS-1 gene mutation. Study results showed crizotinib exhibited marked antitumor activity in this population with an objective response rate of 66% by an independent radiology review. There was 1 complete response and 32 partial responses. The median duration of response was 18.3 months. [181]

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