GSK closed its $10.6 billion Nuvalent acquisition on July 15. One week later, FDA approved Jideytro (zidesamtinib) for ROS1-positive non-small cell lung cancer, nearly two months ahead of its September 18 PDUFA date. It’s GSK’s first-ever lung cancer approval.
The drug treats adults with advanced ROS1-positive NSCLC who already failed a prior ROS1 inhibitor. In the Arros-1 trial, it posted a 44% objective response rate across 117 patients, with 82% of responders still in remission at six months and 69% at 12 months. Among 50 patients with brain metastases, 48% responded, including 22% complete responses. GSK’s chief scientific officer Tony Wood called it validation of “the urgent need for additional effective and tolerable treatments” in a July 22 statement.
That’s a fast payoff on a big check. A week from close to approval is the kind of turnaround that makes a $10.6 billion price tag look defensible to shareholders who watched GSK complete the deal just last week.
The bigger test is commercial. GSK is touting “multi-blockbuster potential,” but rival Ibtrozi, from Nuvation Bio, has similar CNS-penetrant, TRK-sparing design and posted just $18.5 million in first-quarter 2026 revenue despite a broader, line-agnostic label. Jideytro’s current label is narrower: prior-ROS1-inhibitor patients only, with a first-line expansion still pending.
Next up for GSK’s Nuvalent haul: neladalkib, a fourth-generation ALK inhibitor, faces its own FDA target date of November 27.
Sarah Chen