The US Food and Drug Administration has approved zidesamtinib (Jideytro) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer following prior treatment with a ROS1 kinase inhibitor, according to a press release from GSK. The approval follows the US Food and Drug Administration's Breakthrough Therapy and Orphan Drug designations and was granted ahead of the agency's original September 18, 2026, target action date.

The approval is based on results from the global, single-arm, phase 1/2 ARROS-1 trial in patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) previously treated with a ROS1 inhibitor. Among 117 patients, the objective response rate was 44%. Responses were ongoing in 82% of responding patients at 6 months and in 69% at 12 months. According to the company, responses were also observed in patients with brain metastases and ROS1 resistance mutations.

GSK stated that zidesamtinib was designed for high ROS1 selectivity, broad coverage of ROS1 resistance mutations, and blood-brain barrier penetration. According to the company, the agent was developed to address efficacy and tolerability challenges associated with treating ROS1-positive NSCLC. Approximately 50,000 people worldwide are diagnosed with ROS1-positive NSCLC each year, according to the company.

In the pooled safety population of 446 patients, the most common adverse reactions reported in at least 15% of patients were edema, peripheral neuropathy, constipation, fatigue, and dyspnea.

According to the press release, ARROS-1 is also assessing zidesamtinib as a first-line treatment in patients who have not previously received a ROS1 inhibitor.

Source: GSK