FDA approves zidesamtinib for ROS1 positive non-small-cell lung cancer

FDA

24 July 2026 - On 22 July 2026, the FDA approved zidesamtinib (Jideytro, Nuvalent) for adults with locally advanced or metastatic ROS1-positive non-small-cell lung cancer who received at least one prior ROS1 tyrosine kinase inhibitor.

Efficacy was evaluated in ARROS-1, a multi-centre, single-arm, open-label, multi-cohort trial in patients with previously treated locally advanced or metastatic ROS1 positive non-small-cell lung cancer.

Read FDA News 

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration