GSK plc has secured its first-ever approved medicine in lung cancer after the US FDA granted approval to Jideytro (zidesamtinib) for adult patients with previously treated ROS1-positive non-small cell lung cancer.
The approval arrived ahead of the original target action date of 18 September 2026, marking a significant regulatory milestone for the British pharmaceutical giant.
Jideytro entered GSK’s portfolio through its recently completed acquisition of Nuvalent, Inc., and carries both FDA Breakthrough Therapy and Orphan Drug Designations.
The drug was specifically developed to tackle key efficacy and tolerability challenges associated with treating ROS1-positive non-small cell lung cancer in clinical practice.
Its next-generation design aims to combine high target-selectivity, broad coverage of ROS1 resistance mutations, and blood-brain barrier penetration to address disease spread to the brain.
Approximately 50,000 people worldwide receive a ROS1-positive non-small cell lung cancer diagnosis each year, representing a substantial patient population in need of improved treatment options.
Jideytro will enter a competitive market, going up against Bristol Myers Squibb’s Augtyro, as well as established treatments including Roche’s Rozlytrek and Pfizer’s Xalkori.
The FDA based its approval decision on data from the ARROS-1 phase 1/2 clinical trial, which enrolled 117 previously treated patients and demonstrated an objective response rate of 44%.
The trial also showed a duration of response rate of 82% at six months and 69% at the twelve-month milestone, including durable results in patients with brain metastases.
A GSK spokesperson said, “We are working to ensure patients have access to Jideytro as soon as possible with medicine available in pharmacies in the coming weeks.”
Beyond Jideytro, GSK is advancing neladalkib (NVL-655), another medicine from the Nuvalent acquisition targeting ALK-altered non-small cell lung cancer, currently under FDA review with a target decision date of 27 November 2026.
The company is also developing NVL-330, an investigational treatment for patients with HER2-altered non-small cell lung cancer, further expanding its oncology pipeline from the Nuvalent deal.
GSK is additionally progressing risvutatug rezetecan, known as Ris-Rez, a B7-H3-targeted antibody-drug conjugate licensed from Hansoh Pharma Inc., which recently reported positive phase III data in relapsed small-cell lung cancer.
The string of lung cancer pipeline advances signals a deliberate strategy by GSK to establish a meaningful and competitive presence across multiple thoracic oncology indications.