22nd Jul 2026 19:36
(Alliance News) - GSK PLC on Wednesday said that the US Food & Drug Administration has approved zidesamtinib, branded as Jideytro, for previously treated ROS1-positive non-small cell lung cancer.
The London-based pharmaceutical manufacturer said the approval was based on Arros-1 phase I/II trial demonstrating meaningful and durable responses in patients with locally advanced or metastatic disease. It is GSK's first approved medicine in lung cancer.
The approval comes ahead of the original target action date of September 18, and follows the FDA's breakthrough therapy and orphan drug designations.
Jideytro, part of the portfolio from the recently completed acquisition of Nuvalent Inc, was developed to address key efficacy and/or tolerability challenges of treating ROS1-postive NSCLC. Its next-generation design aims to combine high target-selectivity, broad coverage of ROS1 resistance mutations and blood-brain barrier penetration to address disease in the brain.
"The rapid progression of Jideytro from development to approval reflects both the strength of the underlying science and the urgent need for additional effective and tolerable treatments for ROS1-positive lung cancer. Today's approval provides an important new option for these patients and supports our strategy to acquire assets with validated targets that could meaningfully improve standards of care," said GSK Chief Scientific Officer Tony Wood.
Shares in GSK closed up 0.9% at 1,910.50 pence each in London on Wednesday.
By Jeremy Cutler, Alliance News reporter
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