The U.S. Food and Drug Administration approved Bayer’s oral HER2‑directed drug Hyrnuo (sevabertinib) for adults with locally advanced or metastatic non‑squamous NSCLC harboring activating HER2 mutations after prior systemic therapy. The approval followed priority review and earlier breakthrough designation and establishes a targeted option for this genomically defined cohort. Alongside the drug approval, Thermo Fisher Scientific secured FDA clearance for an NGS‑based companion diagnostic, the Ion Torrent Oncomine Dx Target Test, to identify patients whose tumors carry the relevant HER2 tyrosine kinase domain (TKD) mutations. The paired approvals create a clear biomarker‑drug pathway for patient selection and reimbursement discussions. The approvals underscore the continued role of precision diagnostics in enabling targeted oncology launches. Commercial uptake will depend on testing access in community oncology settings and payer coverage for both drug and companion diagnostic.