Bayer has secured US regulatory approval for sevabertinib as first-line therapy in adults with advanced non-small cell lung cancer (NSCLC) carrying HER2 (ERBB2) activating mutations, extending the oral, non-covalent, reversible tyrosine kinase inhibitor (TKI) beyond its November 2025 approval in previously treated, non-squamous disease with HER2 tyrosine-kinase-domain activating mutations.

The asset inhibits both EGFR and HER2 mutants, including HER2 exon 20 insertions, and the label expansion rests on the Phase I/II SOHO-01 study, where treatment-naive patients (n=73) achieved a 75.3% objective response rate (ORR), 89.0% disease control rate (DCR), 12.2-month median duration of response (DOR), and 13.5-month median progression-free survival (PFS), versus 66.7% ORR, 81.5% DCR, 9.5-month DOR, and 8.3-month PFS in 81 patients who were systemic-therapy-experienced but HER2-targeted-naive.

The readout matters because first-line HER2-mutant NSCLC has lacked a labelled oral targeted standard, and a 75%-plus response rate with over a year of median PFS positions sevabertinib against ADCs such as AstraZeneca's trastuzumab deruxtecan and Daiichi Sankyo's patritumab deruxtecan-class competition, while keeping Bayer relevant in precision lung cancer after its radiology-and-cardiology-heavy portfolio mix.