The drug, branded as Jideytro, is now authorized for patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer — a rare form of the disease — after prior treatment with a ROS1 inhibitor, the British drugmaker said.
The FDA's decision was backed by data from an early- to mid-stage trial involving patients previously treated with ROS1-targeted medicines, according to the company.
The drug was part of GSK's over-$10 billion buyout of U.S. biotech Nuvalent announced last month, as the British company looks to strengthen its cancer drug portfolio.
In the trial, 44% of 117 patients had their tumours shrink or disappear, and among those who responded to the treatment, 82% were still responding at six months and 69% at 12 months, GSK said.
