Bayer Wins Japanese Nod for Hyrnuo in HER2 Unresectable Non-small Cell Lung Cancer

02:51 AM EDT, 08/24/2026 (MT Newswires) -- Bayer (BMW.F) secured approval from the Japanese Ministry of Health, Labour, and Welfare for sevabertinib, or Hyrnuo, to treat HER2 mutation-positive unresectable advanced or recurrent non-small cell lung cancer. The approval is backed by data from the ongoing phase 1/2 Soho-01 trial, in which Hyrnuo achieved a primary endpoint of objective response rate of 75.3%, a median duration of response of 12.2 months, and median progression-free survival of 13.5 months, according to a Monday release. Hyrnuo is the first targeted therapy approved in Japan for the indication that can be used regardless of the line of therapy, including as a first-line treatment. The German life science company previously secured the US Food and Drug Administration's approval for Hyrnuo in patients with previously treated advanced HER2-mutant NSCLC. China's National Medical Products Administration also cleared the drug as a monotherapy for adults with unresectable, locally advanced, or metastatic NSCLC whose tumors have HER2 activating mutations.