What is the role of loratinib 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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Lorlatinib (Lorbrena) was approved in March 2021 for patients with metastatic NSCLC whose tumors are ALK positive. It previously received accelerated approval in 2018 for the second- or third-line treatment of ALK-positive metastatic NSCLC. [188]

Approval was based on data from the CROWN study, a phase 3, multicenter, open-label, active-controlled trial evaluating 296 patients with ALK-positive metastatic NSCLC who had not received prior systemic therapy for metastatic disease. Patients were randomized to receive lorlatinib (n=149) or crizotinib (n=147). The median PFS was not estimable in the lorlatinib arm and was 9.3 months (95% CI: 7.6, 11.1) for those treated with crizotinib. Overall survival data were immature at the PFS analysis. The intracranial ORR was 82% in the lorlatinib arm and 23% in the crizotinib arm, with intracranial responses lasting at least 12 months in 79% of the lorlatinib arm and 0% of the crizotinib arm. [189]

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