FDA expands Hyrnuo approval to first-line HER2-mutant non-small cell lung cancer
The FDA has granted accelerated approval to Hyrnuo for first-line treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer carrying activating HER2/ERBB2 tyrosine kinase domain mutations.
The decision expands the use of sevabertinib into the first-line setting for eligible patients with HER2-mutant non-small cell lung cancer.
The approval provides a new targeted treatment option for this molecularly defined patient group and further supports routine HER2 mutation testing in advanced disease.
Field | Content |
Alert Type | FDA accelerated approval |
Company | Bayer |
Drug / Asset | Hyrnuo (sevabertinib) |
Regulator | U.S. Food and Drug Administration |
Indication | Locally advanced or metastatic non-squamous non-small cell lung cancer |
Biomarker | Activating HER2/ERBB2 tyrosine kinase domain mutations |
Treatment Setting | First-line |
What Happened | The FDA granted accelerated approval to Hyrnuo as a first-line treatment option for adults with locally advanced or metastatic non-squamous NSCLC harbouring activating HER2/ERBB2 TKD mutations. |
Why It Matters | The approval expands access to a biomarker-directed therapy earlier in the treatment pathway for patients with HER2-mutant NSCLC. |
Supporting Context | Hyrnuo had previously been approved in patients who had received prior systemic therapy, making this an expansion into the first-line setting. |
Key Takeaway | Sevabertinib is now available as a first-line targeted treatment for eligible adults with HER2-mutant non-squamous NSCLC. |
What to Watch | Confirmatory clinical data and uptake of HER2 mutation testing in first-line advanced NSCLC. |
Primary Source | U.S. Food and Drug Administration |
Relevant Date | 9 September 2026 |
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