The U.S. Food and Drug Administration granted approval to Bayer’s oral HER2‑directed therapy Hyrnuo (sevabertinib) for adults with locally advanced or metastatic non‑squamous NSCLC harboring activating HER2 kinase domain mutations after prior systemic therapy. The approval includes a companion diagnostic from Thermo Fisher (Ion Torrent Oncomine Dx) to identify eligible patients. Hyrnuo received breakthrough therapy designation earlier this year and was prioritized during the FDA review. Bayer framed the approval as a competitive response to recent HER2‑targeted entries and said the oral option expands targeted therapy choices for patients with HER2‑mutant lung cancer. Thermo Fisher’s CDx clearance underscores the continued co‑development of targeted drugs and next‑generation sequencing diagnostics to accelerate patient selection in precision oncology.