The FDA approved GSK's Jideytro (zidesamtinib) for ROS1-positive NSCLC patients previously treated with a ROS1 inhibitor, based on a 44% response rate in the ARROS-1 trial.
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GSK's Jideytro wins FDA approval for 44% response rate in NSCLC
The FDA approved GSK's Jideytro (zidesamtinib) for ROS1-positive non-small cell lung cancer patients who received a prior ROS1 inhibitor, the company said Wednesday.
"The responses observed in ARROS-1, including in heavily pre-treated patients, represent meaningful progress for people living with this disease," Alexander Drilon, chief of the early drug development service at Memorial Sloan Kettering Cancer Center and ARROS-1 trial investigator, said.
The approval was based on 117 patients from the global single-arm ARROS-1 phase I/II trial. The objective response rate was 44 percent, with 82 percent of responders maintaining response at six months and 69 percent at 12 months. Among patients with brain metastases, the intracranial response rate was 48 percent, including 20 percent achieving complete responses. The most common adverse reactions included edema, peripheral neuropathy, constipation, fatigue and dyspnea.
The approval came ahead of the Sept. 18 target action date and marks GSK's first approved lung cancer medicine. Jideytro was part of the portfolio from GSK's recently completed acquisition of Nuvalent Inc., which also yielded neladalkib for ALK-altered NSCLC — now under FDA review with a Nov. 27 decision date — and NVL-330 for HER2-altered NSCLC.
Zidesamtinib was designed as a next-generation ROS1-selective inhibitor to address resistance mutations such as G2032R and penetrate the blood-brain barrier while avoiding off-target TRK-related central nervous system side effects, according to GSK. About 50,000 people worldwide are diagnosed annually with ROS1-positive NSCLC, often non-smokers in their 40s and 50s who may stay on treatment for several years.
The approval gives GSK a foothold in lung cancer, the largest oncology market, and validates its Nuvalent acquisition. Investors will watch for neladalkib's FDA decision in November and the ongoing ARROS-1 expansion into first-line treatment.
This article is for informational purposes only and does not constitute investment advice.
[1] Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer[2] US FDA approves GSK's lung cancer drug[3] Savvas CTE Wins 2026 CODiE Award for Best Career and Technical Education Solution[4] FDA OKs Zidesamtinib as New Option for Resistant ROS1+ NSCLC
