FDA Approval Alert: The Need-to-Know | Zongertinib in HER2+ Metastatic or Unresectable Nonsquamous NSCLC

In August 2025, the FDA granted accelerated approval to the kinase inhibitor zongertinib as a treatment for adult patients with previously treated metastatic or unresectable nonsquamous non–small cell lung cancer harboring HER2 tyrosine kinase domain activating mutations as detected with an FDA-approved test.