• Japan’s MHLW cleared Bayer’s Hyrnuo (sevabertinib) for HER2 (ERBB2) mutation-positive unresectable advanced or recurrent NSCLC.
• Label allows use across all treatment lines, including first-line, making it Japan’s first targeted therapy for this indication.
• Approval relied on SOHO-01 data showing 75.3% ORR in previously untreated advanced or recurrent patients; median PFS 13.5 months.

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