USFDAJul 22, 2026, 12:57 PM
GSK's Jideytro Receives US FDA Approval for ROS1-Positive NSCLC
AI Summary
GSK plc announced that the US Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have received a prior ROS1 kinase inhibitor. This approval, which came ahead of schedule, is based on the ARROS-1 phase I/II clinical trial, showing meaningful and durable responses, including in patients with brain metastases. Jideytro, acquired through the Nuvalent, Inc. acquisition, marks GSK's first approved lung cancer medicine and supports its strategy to improve standards of care.
Key Highlights
- US FDA approved Jideytro (zidesamtinib) for ROS1-positive NSCLC patients previously treated with a ROS1 kinase inhibitor.
- Approval came ahead of the original target action date of September 18, 2026.
- Jideytro was acquired as part of the recently completed acquisition of Nuvalent, Inc.
- The approval is based on the ARROS-1 phase I/II clinical trial results.
- Objective response rate (ORR) was 44% (95% CI: 34-53%) in the overall population (n=117).
- Duration of response (DOR) rates at six and 12 months were 82% and 69%, respectively.
- Jideytro is GSK's first approved medicine in lung cancer.
- GSK is advancing other medicines from the Nuvalent acquisition, including neladalkib and NVL-330.
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