The FDA approved Bayer’s oral HER2-directed therapy Hyrnuo (sevabertinib) for adults with locally advanced or metastatic HER2-mutant non-small-cell lung cancer, granting the drug priority review and breakthrough designations noted earlier in filings. Bayer positioned Hyrnuo as an option for patients who previously received systemic therapy. Thermo Fisher received clearance for an NGS-based companion diagnostic to identify patients eligible for Hyrnuo, enabling clinicians to test tumors for HER2 (ERBB2) tyrosine kinase domain activating mutations. The simultaneous approvals clear the path for a targeted therapy-plus-test launch and should affect treatment pathways in HER2-mutant lung cancer.