The U.S. Food and Drug Administration granted accelerated approval to Bayer’s oral HER2-directed therapy Hyrnuo (sevabertinib) for adults with advanced non–small-cell lung cancer harboring activating HER2 mutations after prior systemic therapy. The approval follows breakthrough and priority-review designations and positions Hyrnuo against recent HER2-targeted entrants. Thermo Fisher Scientific secured FDA clearance for an NGS-based companion diagnostic—its Ion Torrent Oncomine Dx Target Test—to determine patient eligibility for Hyrnuo, enabling molecular testing for ERBB2 TKD activating mutations. Regulators and companies emphasized expedited review and the need for robust molecular testing to match patients to targeted options.