Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ERBB2 TKD activating variants status confers therapeutic sensitivity to Sevabertinib in patients with Lung Non-Squamous Non-Small Cell Carcinoma.
This statement is based on a regulatory approval from the Food and Drug Administration:
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.