The FDA granted accelerated approval to Bayer’s oral HER2-directed therapy Hyrnuo (sevabertinib) for adults with locally advanced or metastatic non-small-cell lung cancer bearing activating HER2 TKD mutations, after prior systemic therapy. Bayer said the approval was supported by clinical data that earned priority review and breakthrough designation earlier this year. Thermo Fisher’s Ion Torrent Oncomine Dx Target Test received FDA clearance as Hyrnuo’s companion diagnostic, enabling patient selection by detecting HER2 mutations in tumor tissue. The dual approvals create an integrated drug–diagnostic pathway for a defined biomarker subgroup in lung cancer and set up immediate commercialization and diagnostic deployment.