Bayer’s Hyrnuo (sevabertinib) received an expanded label in the U.S. to move into first-line treatment for adults with locally advanced or metastatic nonsquamous non-small-cell lung cancer harboring HER2 tyrosine kinase activating mutations. The approval builds on an accelerated approval granted last November for previously treated patients. By expanding to the first-line setting, Bayer effectively enlarges the eligible population earlier in the treatment pathway, increasing clinical adoption and potentially reshaping sequencing discussions with competing HER2-directed regimens. For biotech partners and payers, the signal is that regulators are continuing to extend access to targeted oncology therapies when biomarker-defined subsets demonstrate actionable benefit profiles across lines of therapy.