SerpApi.Org
On Wednesday, the U.S. Food and Drug Administration (FDA) granted early approval to GSK plc’s GSK targeted lung cancer medication, Jideytro (zidesamtinib).
The regulatory green light authorizes the therapy for adult patients facing locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have previously undergone treatment with a ROS1 kinase inhibitor.
Significantly, the agency issued its approval ahead of the original target action date set for September 18.
Overcoming Resistance And Targeting Brain Metastases
Jideytro became part of the pharmaceutical giant’s pipeline following the recently completed acquisition of Nuvalent.
The next-generation inhibitor is specifically engineered to tackle major tolerability and efficacy hurdles associated with current ROS1-positive NSCLC therapies.
Annually, roughly 50,000 people worldwide receive a ROS1-positive NSCLC diagnosis.
Clinical Data Highlights And Future Pipeline
The FDA backed its decision with compelling data from the ARROS-1 phase 1/2 clinical trial.
Among a cohort of 117 previously treated patients, the study revealed an objective response rate of 44%.
The treatment also yielded a duration of response rate of 82% at six months and 69% at the 12-month milestone, demonstrating durable efficacy even in patients with brain metastases.
The milestone marks the first lung cancer drug approval for GSK. The company is actively advancing other assets from the Nuvalent deal, including neladalkib for ALK-altered NSCLC, which awaits an FDA decision by November 27, and NVL-330.
Furthermore, the company continues developing risvutatug rezetecan, a late-stage therapy licensed from Hansoh Pharma Inc., following positive phase 3 results.
GSK Stock Price Activity: GSK shares were up 0.18% at $50.87 at the time of publication on Wednesday,
according to Benzinga Pro data.
Image via Shutterstock
© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
This article FDA Greenlights GSK’s First Lung Cancer Drug Ahead of Schedule originally appeared on Benzinga.com.
