FDA Expands Sevabertinib (Hyrnuo) Accelerated Approval to First-Line HER2-Mutant Non-Small Cell Lung Cancer — 75% Response Rate in Treatment-Naive Patients

The FDA granted accelerated approval to Bayer's sevabertinib (Hyrnuo), an oral HER2 tyrosine kinase inhibitor, for adults with locally advanced or metastatic non-squamous NSCLC harboring HER2 (ERBB2) tyrosine kinase domain-activating mutations who have not received prior systemic therapy — expanding a November 2025 approval that was limited to previously treated patients. The expansion is based on the SOHO-01 trial (NCT05099172): among 69 treatment-naive patients, the confirmed overall response rate was 75% (95% CI: 64-85%), with 73% of responders maintaining response for at least 6 months and 38% for at least 12 months. HER2-activating mutations drive roughly 2-4% of NSCLC cases and have historically lacked a first-line targeted option, with patients defaulting to chemotherapy or chemo-immunotherapy.