The FDA granted approval to Bayer’s oral HER2‑directed drug Hyrnuo for adults with locally advanced or metastatic HER2‑mutant non‑small cell lung cancer, clearing a new targeted option for patients with activating ERBB2 kinase domain mutations. The agency’s decision followed priority review and breakthrough therapy designations granted earlier in the year. Thermo Fisher Scientific won approval for an NGS‑based companion diagnostic—the Ion Torrent Oncomine Dx Target Test—to determine patient eligibility for Hyrnuo. Bayer and Thermo Fisher positioned the tandem approvals as a coordinated launch path to accelerate patient identification and uptake. Regulatory analysts noted the approval tightens competition in HER2‑mutant lung cancer after another recent entrant and underscores the continued importance of paired drug‑and‑diagnostic strategies in targeted oncology.