Hyrnuo (sevabertinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Bayer HealthCare Pharmaceuticals Inc. Hyrnuo (sevabertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219972s000lblCorrected.pdf. Revised November 2025. Accessed December 23, 2025.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
HYRNUO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) ERBB2 TKD activating variants Lung Non-Squamous Non-Small Cell Carcinoma Sevabertinib FDA