A new oral therapy is now available for patients with ROS1-positive lung cancer whose disease has progressed following initial treatment or spread to the brain. Jideytro, a novel lung cancer drug acquired through global healthcare company GSK’s purchase of U.S. biotech Nuvalent, has secured approval from the U.S. Food and Drug Administration (FDA).
GSK announced on July 22 that the FDA approved Jideytro (generic name zidesamtinib) to treat adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who were previously treated with a ROS1 kinase inhibitor. The decision marks GSK’s first FDA approval for a lung cancer therapy. The regulatory approval arrived nearly two months ahead of the agency's original review deadline of September 18.
ROS1-positive lung cancer is a distinct subtype of NSCLC driven by mutations in the ROS1 gene, which fuel the growth and spread of cancer cells. Jideytro is an oral targeted therapy engineered to selectively block the altered ROS1 protein, overcome resistance mutations arising from prior treatments, and penetrate the central nervous system to reach brain metastases. Additionally, the drug is designed to minimize off-target inhibition of tropomyosin receptor kinase (TRK)—a protein structurally similar to ROS1—thereby reducing the risk of central nervous system side effects.
The approval was backed by results from the single-arm Phase 1/2 ARROS-1 trial. Among 117 patients who had previously received a ROS1 targeted therapy, Jideytro achieved an objective response rate of 44%, demonstrating significant tumor shrinkage or complete disappearance. Among responders, 82% maintained their response at six months, and 69% maintained it at 12 months. Notably, tumor responses were also confirmed in patients with measurable brain metastases, offering a critical treatment option for a population that frequently experiences central nervous system spread.
The regulatory green light arrived just one week after GSK completed its acquisition of Nuvalent on July 15 in a deal valuing Nuvalent’s equity at $10.6 billion (approximately 15.7 trillion won). Through the transaction, GSK secured Jideytro alongside two additional pipeline candidates: neladalkib for ALK-positive NSCLC and NVL-330 for HER2-mutant lung cancer.
To establish Jideytro as a flagship product, GSK will need follow-on clinical trials to broaden its indication. While the current label restricts use to patients with prior ROS1 inhibitor exposure, GSK plans to pursue approval as a first-line therapy for newly diagnosed patients.
Jideytro enters a competitive ROS1-positive market currently served by Pfizer’s Xalkori (generic name crizotinib), Roche’s Rozlytrek (generic name entrectinib), and Bristol Myers Squibb’s Augtyro (generic name repotrectinib). With Jideytro's market entry, competition is expected to heighten around therapeutic efficacy, safety profiles, and central nervous system penetration.
