Lorlatinib for ALK-positive NSCLCJanuary 14, 2019
Lorlatinib (Lorbrena) has been granted US FDA approval to treat patients with ALK-positive metastatic non-small cell lung cancer (NSCLC), Pfizer Inc announced.
Lorlatinib, a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), is indicated for patients whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.
This indication is approved under accelerated approval based on tumour response rate and duration of response.
The approval was based on a non-randomized, dose-ranging and activity-estimating, multi-cohort, multicentre phase 1/2 study, B7461001, evaluating Lorbrena for the treatment of patients with ALK-positive metastatic NSCLC, who were previously treated with one or more ALK TKIs. A total of 215 patients with ALK-positive metastatic NSCLC were enrolled across various subgroups based on prior treatment. Among these patients, overall response rate (ORR) was 48 percent and importantly, 57 percent had previous treatment with more than one ALK TKI.