The FDA approved Nuvalent’s lung cancer medicine on Wednesday—about two months earlier than projected—highlighting early execution from GSK’s newly completed $10.6 billion Nuvalent acquisition. The regulator cleared the drug less than a week after GSK closed the deal, giving GSK an immediate path to revenue in ROS1-positive NSCLC. The decision also reinforces how designation pathways such as breakthrough therapy and orphan drug can accelerate review timelines. Nuvalent previously marketed the therapy as potentially offering longer duration and a side-effect profile intended to differ from existing ROS1 options. GSK’s broader strategy is to build out oncology as it continues to integrate the acquired portfolio and advance additional assets that are still pending regulatory determinations.