The US FDA granted an expanded accelerated approval for Bayer’s Hyrnuo (sevabertinib) to treat adults with locally advanced or metastatic nonsquamous non-small cell lung cancer harboring HER2 tyrosine kinase domain activating mutations in the first-line setting. The update builds on the label already approved for previously treated patients. The new approval expands eligible patient populations beyond the post-systemic-therapy group, shifting the drug’s positioning earlier in the treatment sequence. Bayer’s Hyrnuo program will likely face increased competition from HER2-directed regimens as first-line choices broaden with biomarker-driven testing. For clinicians, the decision reinforces the importance of companion diagnostic-driven stratification for HER2-mutant NSCLC. For developers, it demonstrates how incremental label expansions can materially change commercial trajectories when accelerated-approval data support earlier-line use.