FDAapproval72% confidence
FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (breast cancer) as AstraZeneca.
Regulatory Analysis
On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI).
Supporting Context
- Therapeutic area
- Oncology · Breast Cancer
- Sub-indication
- Breast Cancer
Related signal: Datroway Approved in EU for Metastatic TNBC as First TROP2-Directed Therapy