Jideytro Approved for Previously Treated ROS1+ NSCLC
On July 22, 2026, the US Food and Drug Administration (FDA) approved GSK’s Jideytro™ (zidesamtinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have received a prior ROS1 kinase inhibitor. Jideytro is a next-generation, ROS1-selective tyrosine kinase inhibitor (TKI) designed to address resistance mutations and penetrate the blood-brain barrier to improve outcomes in patients with central nervous system (CNS) metastases. Jideytro carries warnings for serious central nervous system adverse reactions, including dizziness, ataxia (poor muscle control), cognitive impairment, and psychiatric disorders, which may require treatment interruption, dose reduction, or discontinuation. The recommended dose is 100mg once daily with or without food until disease progression or unacceptable toxicity. The approval occurred nearly two months ahead of the original FDA target action date of Sept. 18, 2026. The prescribing information may be found here.
At a Glance
- Brand Drug: Jideytro™ (zidesamtinib)
- Manufacturer: GSK (via its recent acquisition of Nuvalent)
- Date Approved: July 22, 2026
- Indication: For the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor
- Dosage Forms Available: 25mg and 100mg tablets
- Launch Date: Not yet known.
- Estimated Annual Cost: Not yet announced.
- FDA Designations: Breakthrough Therapy. Orphan Drug.
- ROS1-positive NSCLC is a rare molecular subtype of NSCLC accounting for approximately 1% to 2% of NSCLC cases. It is frequently associated with younger patients, non-smokers and a high incidence of brain metastases.
- According to the manufacturer, approximately 50,000 people worldwide are diagnosed annually with ROS1-positive NSCLC.
- Approval was supported by the phase I/II ARROS-1 study, which showed that Jideytro achieved an objective response rate (ORR) of 44% in patients with previously treated ROS1-positive NSCLC. Among responders, 82% maintained their response at six months and 69% maintained their response at 12 months. Among patients with measurable brain metastases, the intracranial ORR was 48%, including a 22% complete response rate.
- Common adverse reactions reported in the pooled safety population included edema, peripheral neuropathy, constipation, fatigue, and dyspnea.
- Jideytro will compete with approved oral ROS1 inhibitors Xalkori® (crizotinib – Pfizer), Rozlytrek® (entrectinib – Roche/Genentech), Augtyro® (repotrectinib – Bristol Myers Squibb), and Ibtrozi™ (taletrectinib – Nuvation Bio).
- Ongoing development for Jideytro includes evaluation as a first-line treatment for patients with treatment-naive NSCLC and in additional ROS1-positive solid tumors.