GSK has secured US FDA approval for Jideytro (zidesamtinib) for adults with locally advanced or metastatic ROS1‑positive non‑small cell lung cancer who have previously received a ROS1 kinase inhibitor.
The decision, granted ahead of the 18 September 2026 target action date, follows Breakthrough Therapy and Orphan Drug designations.
Jideytro, acquired through GSK’s purchase of Nuvalent, was developed to address efficacy and tolerability challenges in ROS1‑positive disease.
Its next‑generation design aims to combine high target‑selectivity, broad coverage of ROS1 resistance mutations and blood‑brain barrier penetration. Around 50,000 people globally are diagnosed with ROS1‑positive NSCLC each year, often non‑smokers in mid‑life who may remain on treatment for several years.
Tony Wood, Chief Scientific Officer, GSK, said: “The rapid progression of Jideytro from development to approval reflects both the strength of the underlying science and the urgent need for additional effective and tolerable treatments for ROS1-positive lung cancer.”
“Today’s approval provides an important new option for these patients and supports our strategy to acquire assets with validated targets that could meaningfully improve standards of care.”
The approval is based on the global single‑arm ARROS‑1 phase I/II trial in previously treated patients.
The study showed meaningful and durable responses, including in those with brain metastases and ROS1 resistance mutations. In the overall population (n=117), the objective response rate was 44% and duration of response rates at six and 12 months were 82% and 69%.
Alexander Drilon, MD, ARROS‑1 investigator, said: “Despite advances in treatment, resistance mutations, disease progression in the brain and treatment-related adverse events continue to create challenges for patients.”
“The responses observed in ARROS-1, including in heavily pre-treated patients, represent meaningful progress for people living with this disease.”
Janet Freeman‑Daily, Co‑Founder and President of The ROS1ders, said: “For patients, the goal is not just more time, but quality time to live life as normally as possible while on treatment.”
“Today’s approval gives patients and their doctors an important new option and represents meaningful progress for our community.”
GSK is advancing additional targeted lung cancer medicines from the Nuvalent acquisition, including neladalkib for ALK‑altered NSCLC and NVL‑330 for HER2‑altered disease, alongside late‑stage development of risvutatug rezetecan.
