The discoveries of EGFR mutations and ALK rearrangements as actionable oncogenic
drivers in non-small-cell lung cancer (NSCLC) has propelled a biomarker-directed treatment …

Abstract The United States Food and Drug Administration (US FDA) has always been a
forerunner in drug evaluation and supervision. Over the past 31 years, 1050 drugs …

Background Lorlatinib, a third-generation inhibitor of anaplastic lymphoma kinase (ALK),
has antitumor activity in previously treated patients with ALK-positive non–small-cell lung …

For a blood-borne cancer therapeutic agent to be effective, it must cross the blood vessel
wall to reach cancer cells in adequate quantities, and it must overcome the resistance …

The central role of dysregulated kinase activity in the etiology of progressive disorders,
including cancer, has fostered incremental efforts on drug discovery programs over the past …

There has been huge progress in the discovery of targeted cancer therapies in recent years.
However, even for the most successful and impactful cancer drugs which have been …

PURPOSE Lorlatinib is a potent, brain-penetrant, third-generation anaplastic lymphoma
kinase (ALK)/ROS1 tyrosine kinase inhibitor (TKI) with robust clinical activity in advanced …

Advanced, anaplastic lymphoma kinase (ALK)–positive lung cancer is currently treated with
the first-generation ALK inhibitor crizotinib followed by more potent, second-generation ALK …

The proto-oncogene ROS1 encodes a receptor tyrosine kinase with an unknown
physiological role in humans. Somatic chromosomal fusions involving ROS1 produce …

Background Most patients with anaplastic lymphoma kinase (ALK)-rearranged or ROS proto-
oncogene 1 (ROS1)-rearranged non-small-cell lung cancer (NSCLC) are sensitive to …