FDA Grants Accelerated Approval to Bayer’s HYRNUO for Advanced HER2-Mutant Lung Cancer

Reuters
2025.11.20 07:32
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The FDA has granted accelerated approval to Bayer's HYRNUO™ (sevabertinib) for treating advanced HER2-mutant lung cancer. This approval is for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations, who have previously received systemic therapy. Sevabertinib is a tyrosine kinase inhibitor, and the approval follows Priority Review and Breakthrough Therapy Designation. Bayer AG announced this on November 20, 2025.