Key Highlights
- The US FDA has approved GSK’s Jideytro (zidesamtinib), a ROS1 selective inhibitor, for adults with previously treated, locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), arriving ahead of its original September 18, 2026 target action date.
- Approval rests on the ARROS-1 Phase I/II trial, where the 117-patient population achieved a 44% objective response rate, with 82% and 69% duration-of-response rates at six and 12 months, respectively, including responses in patients with brain metastases and resistance mutations.
- Jideytro marks GSK’s first-ever approval in lung cancer, stemming from its recently completed Nuvalent acquisition, and joins a broader oncology pipeline that includes neladalkib (under FDA review) and the antibody-drug conjugate Ris-Rez, both advancing behind it.
A Landmark Approval Reflecting the Strength of GSK’s Oncology Push
GSK’s announcement that the FDA has approved Jideytro for ROS1-positive NSCLC marks a significant milestone for a company expanding decisively into lung cancer treatment. Approximately 50,000 people worldwide are diagnosed with ROS1-positive NSCLC each year, often non-smokers in their 40s and 50s who may remain on treatment for years, making the arrival of a next-generation, purpose-built therapy a meaningful development for a patient population that continues to face resistance mutations and disease progression in the brain despite existing treatments.
Inside the Data: What the ARROS-1 Trial Demonstrated
The approval is grounded in results from the global, single-arm ARROS-1 Phase I/II trial, which evaluated zidesamtinib in 117 patients with advanced ROS1-positive NSCLC previously treated with a ROS1 inhibitor. The trial demonstrated an objective response rate of 44%, with duration-of-response rates of 82% at six months and 69% at 12 months, reflecting meaningful and durable benefit even in heavily pre-treated patients, including those with brain metastases and resistance mutations. The most common adverse reactions across the pooled safety population of 446 patients included oedema, peripheral neuropathy, constipation, fatigue, and dyspnoea.
Next-Generation Design Built to Address Longstanding Treatment Challenges
Jideytro was engineered specifically to overcome the efficacy and tolerability limitations that have long challenged ROS1-positive NSCLC treatment, combining high target selectivity, broad coverage of ROS1 resistance mutations, and blood-brain barrier penetration to address disease that has spread to the brain. Tony Wood, GSK’s Chief Scientific Officer, said the drug’s rapid progression 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,” calling it an important new option that supports GSK’s strategy of acquiring assets with validated targets capable of meaningfully improving standards of care.
Part of a Bigger Pattern: GSK’s Expanding Lung Cancer and Oncology Pipeline
Jideytro arrives as GSK’s first approved medicine in lung cancer, built on the foundation of its recently completed Nuvalent acquisition. The company is now advancing additional candidates from that same pipeline, including neladalkib (NVL-655) for ALK-altered NSCLC, currently under FDA review with a target decision date of November 27, 2026, and NVL-330, an investigational treatment for HER2-altered NSCLC. GSK is also progressing risvutatug rezetecan (Ris-Rez), a B7-H3-targeted antibody-drug conjugate in late-stage development, following recently reported positive Phase III results from licensor Hansoh Pharma in relapsed small-cell lung cancer. Together, these programs signal GSK’s clear ambition to become a major, sustained presence in lung and solid tumor oncology.
By