Bayer received approval for Hyrnuo (sevabertinib) from Japan's Ministry of Health, Labour and Welfare (MHLW). The approval date was August 24, 2026. Hyrnuo treats patients with HER2 mutation-positive unresectable advanced or recurrent non-small cell lung cancer (NSCLC).
Hyrnuo is the first targeted therapy approved in Japan for this lung cancer type. It can be used across all lines of therapy, including as a first-line treatment. The SOHO-01 trial data supported the approval. The trial showed a 75.3% objective response rate in previously untreated patients. Hyrnuo is an oral tyrosine kinase inhibitor. It blocks enzymes involved in cancer cell growth.
Hyrnuo received prior approval in the United States in November 2025. It also received approval in China for patients who received prior systemic therapy. The Japanese market expansion reinforces Bayer's precision oncology strategy.