GSK said the U.S. FDA has approved zidesamtinib (now marketed as Jideytro) for adults with locally advanced or metastatic ROS1-positive non-small-cell lung cancer who have received a prior ROS1 kinase inhibitor. The clearance lands about a week after GSK closed its $10.6 billion acquisition of Nuvalent, positioning the deal for faster revenue contribution. The approval supports GSK’s post-deal oncology strategy, adding a next-generation ROS1 selective therapy at a time when competing ROS1 inhibitors have struggled commercially. GSK said the drug is designed for high selectivity and broad coverage of resistance mutations, including activity against brain metastases. With the FDA nod arriving ahead of the typical decision deadline cadence, GSK can now move quickly into U.S. commercialization for Jideytro while monitoring the progress of additional Nuvalent assets still under regulatory review.
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