The US FDA has approved zidesamtinib (Jideytro) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have received a prior ROS1 kinase inhibitor. In preclinical studies, zidesamtinib inhibited the viability of cultured cells expressing ROS1 fusion genes, suppressed tumor growth in mouse models, and demonstrated antitumor activity in intracranial NSCLC xenograft models harboring ROS1 fusions. Clinical evidence In a single-arm clinical trial involving 117 patients with ROS1-positive NSCLC (median age, 57 years), zidesamtinib achieved a confirmed objective response rate of 44%.
Among responders, 82% had a duration of response (DOR) of ≥6 months, and 69% had a DOR of ≥12 months. Dosage and administration Available in tablet form Recommended dosage: 100 mg orally once daily, with or without food, until disease…
