FDA granted accelerated approval of lorlatinib in ALK+ NSCLC

2018-12-04

The nonrandomized, multicenter phase II study (B7461001) included 215 patients with ALK-positive metastatic NSCLC previously treated with ≥1 ALK kinase inhibitors. The major efficacy measures were overall response rate (ORR) and intracranial ORR. The ORR was 48% (95% CI, 42-55), including a complete response (CR) rate of 4% and a partial response (PR) rate of 44%. The intracranial ORR in 89 patients with measurable CNS lesion was 60% (95% CI, 49%-70%), with a 21% CR rate and a 38% PR rate. The median response of duration was 19.5 months (95% CI, 12.4 – not reached). This study demonstrates that lorlatinib is a promising treatment option in drug-resistant ALK-positive NSCLC patients.

Source : Lorlatinib prescribing information. FDA. Accessed November 13, 2018. https://bit.ly/2P6uini.