Bayer's Sevabertinib Wins Accelerated US FDA Approval for Non-small Cell Lung Cancer

11:50 PM EDT, 09/09/2026 (MT Newswires) -- Bayer (BAYN.F) said Wednesday sevabertinib secured the US Food and Drug Administration's accelerated approval for treating HER2-mutant non-small cell lung cancer, or NSCLC. The oral drug is indicated as a first-line treatment option for adult patients with locally advanced or metastatic non-squamous NSCLC with HER2 tyrosine kinase domain activating mutations. The accelerated approval was based on data from the ongoing phase 1/2 Soho-01 study, in which an objective response rate of 75% among patients naïve to HER2-targeted therapy was observed. The life science company added that continued approval of sevabertinib for the indication may be subject to the verification and description of its clinical benefit in the ongoing late-stage Soho-02 confirmatory study.