GSK said the U.S. FDA has approved Jideytro (zidesamtinib), delivering its first regulatory win from the company’s recently closed $10.6 billion Nuvalent acquisition. The drug is indicated for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who previously received a ROS1 kinase inhibitor. GSK received the nod on Wednesday, ahead of the expected Sept. 18 decision deadline, after Nuvalent’s asset entered development with “breakthrough therapy” and “orphan drug” designations that can accelerate reviews. GSK also is positioning the therapy to address resistance mechanisms and central nervous system involvement that often drive progression. The approval extends GSK’s ongoing oncology push built through multiple recent deals, including assets acquired alongside Nuvalent and earlier transactions tied to its cancer pipeline expansion. Analysts will now focus on commercial uptake for a ROS1-restricted population and on timelines for Nuvalent’s additional FDA review-stage medicine. For Nuvalent, the outcome represents an early payoff for GSK’s acquisition execution only weeks after deal close, setting a near-term proof point for the transaction’s thesis around next-generation targeted oncology medicines.