Regulatory approval
Published by the Food and Drug Administration. Accelerated
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.
This is written in the approval document.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| FDA (1) | ERBB2 TKD activating variants | Lung Non-Squamous Non-Small Cell Carcinoma | Sevabertinib |