Bayer's Lung Cancer Drug Sevabertinib Wins Breakthrough Therapy Designations in US, China

03:22 AM EST, 01/06/2026 (MT Newswires) -- Bayer's (BAYN.F) sevabertinib secured breakthrough therapy designations in the US and China as a first-line treatment for locally advanced or metastatic non-small cell lung cancer, or NSCLC, with HER2-activating mutations. The designations from the US Food and Drug Administration and China's Center for Drug Evaluation are based on preliminary clinical evidence from the cohort F of the ongoing phase 1/2 Soho-01 clinical trial, according to a Tuesday release. The cohort includes patients who have not received prior treatment. Sevabertinib, sold under the Hyrnuo brand, was previously granted accelerated approval in the US for patients with previously treated advanced HER2-mutant NSCLC.