GSK’s recently acquired Nuvalent asset, zidesamtinib (branded Jideytro), received FDA approval in ROS1-positive metastatic non-small-cell lung cancer for adults previously treated with a ROS1 kinase inhibitor. The clearance came ahead of the later-September regulatory deadline and kicks off earlier commercialization for the oncology portfolio GSK built through the $10.6 billion Nuvalent deal. The approval follows GSK’s acquisition of Nuvalent, which included another compound, neladalkib, still under FDA review. With ROS1-positive NSCLC representing a smaller molecular subset, the near-term commercial strategy will depend on how well the drug’s performance translates versus existing targeted therapies. For GSK, the decision provides an immediate return on its largest oncology acquisition in years and strengthens its effort to expand beyond its historically strong respiratory and HIV franchises. Competition in ROS1-driven disease is already crowded, so label positioning and market access discussions will be key as GSK moves from approval to launch.