Bayer receives Japanese approval for lung cancer drug Hyrnuo

Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Bayer's cancer therapy, Hyrnuo (sevabertinib), for the treatment of patients with HER2-mutated non-small cell lung cancer (NSCLC). This approval marks the first targeted therapy in Japan for this indication that can be used regardless of the patient's previous lines of treatment, meaning it can be utilized as a first-line therapy.

The decision is supported by data from the Phase I/II SOHO-01 study. In a group of 73 patients with advanced disease who had not previously received systemic therapy, the drug achieved an objective response rate of 75.3 percent. The median duration of response was 12.2 months, with a median progression-free survival of 13.5 months. Reported side effects included diarrhea, skin rash, and nail bed inflammation, with only 3 percent of patients discontinuing treatment due to adverse events.

This regulatory milestone follows previous approvals for sevabertinib in the United States and China, expanding Bayer's oncology market presence. In the U.S., the FDA previously granted accelerated approval, and the drug is currently undergoing priority review for use as a first-line therapy.