FDA Approves GSK Jideytro for ROS1+ NSCLC
The FDA approves GSK Jideytro (zidesamtinib) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer after a prior ROS1 kinase inhibitor. GSK's July 22, 2026 announcement said the decision arrived ahead of the original September 18, 2026 target action date and rests on the ARROS-1 trial.
Contents10 sections
Key Takeaways
- FDA approved Jideytro (zidesamtinib) on July 22, 2026 for previously treated ROS1-positive advanced NSCLC; GSK reported Breakthrough Therapy and Orphan Drug designations.
- ARROS-1 (NCT05118789) showed a 44% ORR in 117 prior ROS1 inhibitor–treated patients, with 6- and 12-month DOR rates of 82% and 69%.
- Common adverse reactions (≥15%) in the pooled safety set (n=446) included oedema, peripheral neuropathy, constipation, fatigue, and dyspnoea.
- GSK called Jideytro its first lung-cancer approval and said it came from the Nuvalent portfolio.
Jideytro (zidesamtinib) at a glance
| Field | Detail |
|---|---|
| Drug | Jideytro (zidesamtinib) |
| Company | GSK plc (Nuvalent portfolio) |
| FDA action | Approval announced July 22, 2026 (ahead of Sept 18, 2026 PDUFA) |
| Indication | Adults with locally advanced or metastatic ROS1-positive NSCLC after a prior ROS1 kinase inhibitor |
| Class | ROS1-selective kinase inhibitor |
| Pivotal evidence | ARROS-1 Phase 1/2 (NCT05118789); n=117 efficacy population |
| Key efficacy | ORR 44% (95% CI 34–53%); DOR 82% at 6 months, 69% at 12 months |
What did the FDA approve?
GSK said the FDA approved Jideytro for adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor. The company described zidesamtinib as a next-generation ROS1-selective inhibitor designed for resistance mutations and blood–brain barrier penetration.
Details are in GSK's July 22 PR Newswire release on Jideytro.
What did ARROS-1 show?
Approval rests on the global single-arm ARROS-1 Phase 1/2 study in advanced ROS1-positive NSCLC after prior ROS1 inhibitor therapy. In the overall efficacy population (n=117), ORR was 44% (95% CI 34–53%). Duration of response rates were 82% at six months and 69% at 12 months.
GSK said responses included patients with brain metastases and ROS1 resistance mutations. Trial registration is on ClinicalTrials.gov for ARROS-1 (NCT05118789).
What safety signals were reported?
In the pooled safety population (n=446), the most common adverse reactions (≥15%) were oedema, peripheral neuropathy, constipation, fatigue, and dyspnoea. The U.S. Prescribing Information will define the full labeled safety profile; GSK said the label would be posted with the approval materials.
- Efficacy n=117 prior ROS1-inhibitor patients in ARROS-1
- Safety pooled n=446
- Prior designations cited: Breakthrough Therapy and Orphan Drug
How does this fit GSK's lung strategy?
GSK framed Jideytro as its first approved lung-cancer medicine and part of assets from the Nuvalent acquisition. The company also cited neladalkib (NVL-655) for ALK-altered NSCLC under FDA review with a November 27, 2026 target decision date, plus NVL-330 in HER2-altered NSCLC and risvutatug rezetecan in late-stage small-cell lung cancer development.
GSK estimated about 50,000 people worldwide are diagnosed each year with ROS1-positive NSCLC, often non-smokers in their 40s and 50s.
What remains uncertain?
ARROS-1 approval evidence is single-arm; first-line data in ROS1 inhibitor–naive patients are still being generated in ARROS-1 and are not the basis of this label. Comparative overall survival versus other approved ROS1 TKIs was not the primary approval package described in the company release. Real-world CNS control and tolerability versus first-generation agents need post-marketing follow-up.
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Frequently Asked Questions
What did the FDA approve for Jideytro (zidesamtinib)?
On July 22, 2026, the FDA approved Jideytro (zidesamtinib), a ROS1-selective inhibitor from GSK, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who previously received a ROS1 kinase inhibitor.
What did the ARROS-1 trial show for zidesamtinib?
In ARROS-1 (NCT05118789), among 117 patients previously treated with a ROS1 inhibitor, the objective response rate was 44% (95% CI 34–53%). Duration of response rates were 82% at six months and 69% at 12 months.
How does Jideytro fit into GSK's lung cancer portfolio?
GSK said Jideytro is its first approved medicine in lung cancer and came from the Nuvalent acquisition. Neladalkib (NVL-655) for ALK-altered NSCLC remains under FDA review with a target decision date of November 27, 2026.
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