HYRNUO® (Sevabertinib)

The FDA on November 19, 2025, granted accelerated approval to HYRNUO®, a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous Non-Small Cell Lung Cancer (NSCLC) whose tumors have HER2 (ERBB2) Tyrosine Kinase Domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. HYRNUO® is a product of Bayer HealthCare Pharmaceuticals Inc.