GSK secured U.S. FDA approval for zidesamtinib (branded Jideytro) in ROS1-positive non-small-cell lung cancer, delivering an unusually fast regulatory win for the company just after its $10.6 billion acquisition of Nuvalent closed. The approval covers adults with locally advanced or metastatic ROS1-positive disease who previously received a ROS1 kinase inhibitor. GSK previously characterized Jideytro as a next-generation, ROS1-selective option designed to broaden resistance coverage and address clinically important issues such as brain metastases. The FDA action comes ahead of the original scheduled decision timeline and follows Nuvalent’s breakthrough therapy and orphan drug designations. For investors, the approval represents the first tangible monetization step from the Nuvalent buyout, while GSK continues to advance additional acquired oncology assets, including neladalkib, which remains under FDA review.