GSK earns FDA approval for Jideytro

GSK secured FDA approval for Jideytro (zidesamtinib), its first lung cancer medicine, for ROS1-positive NSCLC after prior ROS1 inhibitor treatment. The approval, based on ARROS-1 trial data showing a 44% objective response rate, came ahead of the September 18 target date. Jideytro is part of GSK’s $10.6 billion acquisition of Nuvalent, fueling its push to expand its oncology portfolio. The drug is a next-generation ROS1 inhibitor designed to be selective and to cross the blood-brain barrier to address brain metastases and resistance mutations. It will compete with existing ROS1 therapies like Xalkori and Rozlytrek and faces sales uncertainty in a competitive market. GSK's leadership positions this approval as a milestone in rebuilding its cancer drug business under CEO Luke Miels, with further Nuvalent assets progressing, including neladalkib.