Jideytro wins US approval for previously treated ROS1-positive non-small cell lung cancer

GSK has reently announced that the US FDA has approved Jideytro, a ROS1 selective inhibitor, for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have previously received a ROS1 kinase inhibitor. The decision arrived ahead of the original target action date of 18 September 2026 and follows earlier FDA Breakthrough Therapy and Orphan Drug Designations for the medicine.

Jideytro, which entered the GSK portfolio through the recently completed acquisition of Nuvalent, was developed to address significant efficacy and tolerability challenges in the treatment of ROS1-positive non-small cell lung cancer. Its next-generation architecture seeks to combine precise target selectivity with broad coverage of ROS1 resistance mutations and the ability to penetrate the blood-brain barrier, giving it the capacity to tackle disease that has spread to the brain. Around 50,000 people worldwide receive a diagnosis of ROS1-positive non-small cell lung cancer each year, a population that skews toward non-smokers in their forties and fifties who may remain on treatment for many years.

“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,” said Tony Wood, Chief Scientific Officer, GSK.

Data from the global single-arm ARROS-1 Phase I/II clinical trial in patients with advanced or metastatic ROS1-positive non-small cell lung cancer previously treated with a ROS1 inhibitor form the basis of the approval. The trial demonstrated clinically meaningful and lasting responses, including in patients with brain metastases and those harbouring ROS1 resistance mutations. Across the overall population of 117 patients, an objective response rate of 44% was recorded, with duration of response rates of 82% at six months and 69% at twelve months.

Among the most frequently occurring adverse reactions, each reported in at least 15% of patients across the pooled safety population of 446 individuals, were oedema, peripheral neuropathy, constipation, fatigue, and dyspnoea.

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Related Topics and Keywords

Jideytro, lung cancer, non-small cell lung cancer, positive non-small cell lung cancer, ROS1-positive non-small cell lung cancer