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The FDA on July 22, 2026 approved Jideytro (zidesamtinib), a once-daily tablet, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have received a prior ROS1 kinase inhibitor.
Zidesamtinib inhibits the ROS1 tyrosine kinase, including forms that carry the resistance mutations seen after earlier drugs. In laboratory models it blocked cells with the G2032R mutation and showed activity against a ROS1-driven tumor implanted in the brain.
ARROS-1 (NCT05118789) was a single-arm trial. Among 117 patients previously treated with a ROS1 inhibitor, half of whom had received two or more, 44% had a confirmed response by blinded central review, and 69% of those responses lasted at least 12 months. The response rate was 49% after one prior ROS1 inhibitor and 38% after two or more. Of 50 patients with measurable brain metastases, 48% responded.
Warnings include central nervous system effects, QTc prolongation, interstitial lung disease, skeletal fractures and pancreatic toxicity.
Jideytro came from Nuvalent, which GSK finished acquiring on July 15, a week before the decision. The trial had no comparator arm, so the response rates are uncontrolled in the labeled population.
Sources: FDA prescribing information; Drugs@FDA, NDA 220185; FDA approval notice; GSK press release; ARROS-1 (NCT05118789)
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