GSK agreed to acquire Nuvalent for $10.6 billion, adding two near-commercial non-small cell lung cancer (NSCLC) programs to its pipeline and positioning the company for potential approvals later this year. The deal brings ROS1 inhibitor zidesamtinib (NVL-520) and ALK inhibitor eladalkib (NVL-655), both under FDA review. The FDA set target decision dates of September 18 for zidesamtinib and November 27 for neladalkib. Both candidates carry Breakthrough Therapy and Orphan Drug designations and are designed to be highly selective to limit central nervous system adverse events, including those expected from off-target TRK family inhibition. Nuvalent’s third NSCLC asset, NVL-330, is a HER2 inhibitor in Phase I testing. The transaction also includes additional preclinical programs, while GSK framed the acquisition as a multi-product strategy aimed at meaningfully addressing efficacy and tolerability gaps in oncology. For investors and competitors, the headline is timing: if approved, GSK expects to launch both lead products this year—an immediate revenue catalyst and a further intensification of the kinase-selective, next-generation lung cancer race.