FDA expands Hyrnuo accelerated approval to first-line HER2-mutated non-small cell lung cancer
The FDA has expanded the accelerated approval of Hyrnuo to include first-line treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer harbouring HER2/ERBB2 tyrosine kinase domain activating mutations.
Sevabertinib, marketed as Hyrnuo, can now be used in the first-line setting for eligible patients with HER2-mutated advanced non-small cell lung cancer, extending its previous indication beyond previously treated disease.
The approval broadens access to a targeted oral therapy for a molecularly defined group of lung cancer patients and reinforces the growing role of biomarker testing in treatment selection.
Field | Content |
Alert Type | Approval |
Drug Name | Sevabertinib |
Brand Name | Hyrnuo |
Company | Bayer |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | Accelerated approval expansion |
Indication | First-line treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer harbouring HER2/ERBB2 tyrosine kinase domain activating mutations |
Therapy Area(s) | Oncology; lung cancer |
Biomarker | HER2/ERBB2 TKD activating mutation |
Geography | United States |
What Happened | The FDA expanded the accelerated approval of Hyrnuo (sevabertinib) to include first-line treatment of eligible adults with HER2/ERBB2-mutated advanced non-squamous NSCLC. |
Why It Matters | The expanded indication moves Hyrnuo into the first-line setting for a molecularly selected lung cancer population that previously had more limited targeted treatment options. |
Supporting Context | Hyrnuo had previously been approved for patients with HER2-mutated advanced NSCLC following prior systemic therapy. |
Key Takeaway | Hyrnuo can now be used as a first-line targeted treatment for eligible patients with HER2-mutated advanced non-squamous NSCLC. |
What to Watch | Adoption of HER2 mutation testing in first-line NSCLC and confirmatory evidence supporting the accelerated approval. |
Primary Source | U.S. Food and Drug Administration |
Relevant Date | 9 September 2026 |
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