Bayer won accelerated FDA approval for Hyrnuo (sevabertinib) in adults with advanced HER2‑mutant non‑small‑cell lung cancer after prior systemic therapy. The decision positions Hyrnuo to compete in a crowded HER2‑directed lung cancer market and follows breakthrough designation and priority review steps. Thermo Fisher Scientific’s Ion Torrent Oncomine Dx Target Test received clearance as Hyrnuo’s companion diagnostic, enabling genomic selection of patients with activating HER2 TKD mutations. Bayer and Thermo Fisher said the combined approvals will support targeted prescribing and lab adoption for the therapy in the U.S. The approvals intensify competition among oral HER2 inhibitors and underline the continuing importance of paired drug‑CDx strategies to accelerate market access for targeted oncology agents.