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U.S. FDA Grants Accelerated Approval to Bayer's HYRNUO® (sevabertinib) as a First-Line ...
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Fusion42 · 10 September 2026 · Fusion42 review
The U.S. FDA has granted accelerated approval to Bayer's HYRNUO (sevabertinib) for first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer that have HER2 activating mutations, based on strong trial response data. Continued approval depends on confirmatory Phase III trial results.
This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it between 9 Sep 2026 and 10 Sep 2026.
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You can now enter or expand in first-line HER2-mutated NSCLC treatment in the US with an FDA-approved drug, creating a critical window to align with diagnostic testing labs and oncology centres before confirmatory trial results arrive.
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3 sources · first reported 9 Sep 2026 · latest 10 Sep 2026
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