GSK (GSK) said Wednesday the US Food and Drug Administration has approved Jideytro, a ROS1-selective inhibitor, to treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have previously received a ROS1 kinase inhibitor.
The approval, based on the phase I/II Arros-1 trial, comes ahead of the original Sept. 18 target action date after the FDA granted Jideytro Breakthrough Therapy and Orphan Drug designations.
The therapy aims to combine high target-selectivity, broad coverage of ROS1 resistance mutations, and blood-brain barrier penetration to address disease in the brain, the company added.
Jideytro is GSK's first approved medicine in lung cancer.
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