FDA Just Approved a New Targeted Lung Cancer Drug: Who Qualifies for Jideytro Treatment

The U.S. Food and Drug Administration approved Jideytro (zidesamtinib) on July 22, 2026, for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have already received at least one prior ROS1 kinase inhibitor. The approval was announced by GlaxoSmithKline and arrived nearly two months ahead of the drug's original target action date of September 18, 2026, a timing that reflects the strength of the supporting evidence and the FDA's Breakthrough Therapy and Orphan Drug designations granted to zidesamtinib during its development.

This marks GSK's first approved medicine in lung cancer. The drug was developed by Nuvalent, which GSK acquired for $10.6 billion in June 2026.