Targeted treatment with tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC) with proven genetic alterations that predict its efficacy leads to significant improvements in treatment outcomes. These genetic aberrations also include rearrangement of the ALK (anaplastic lymphoma kinase) gene and the ROS1 gene.
Lorlatinib is a selective 3rd generation ALK/ROS1 tyrosine kinase inhibitor that has been shown to be effective in the failure of lower generation TKI therapy. In May 2019, lorlatinib monotherapy was approved by the European Medicines Agency (EMA) for the treatment of adult patients with advanced ALK-positive NSCLC who developed disease progression after treatment with alectinib or ceritinib or after treatment with crizotinib and at least one other ALK TKI.