Therapeutic Response

ERBB2 oncogenic variants status confers therapeutic sensitivity to Trastuzumab deruxtecan in patients with Non-Small Cell Lung Cancer.

Statements

Source and description
Enhertu (trastuzumab deruxtecan) [product information]. EMA. The European Medicines Agency (EMA) has authorized trastuzumab deruxtecan for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have an activating HER2 (ERBB2) variant and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
Enhertu (trastuzumab deruxtecan) [package insert]. FDA. The U.S. Food and Drug Administration granted accelerated approval to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. The product label states that these indications are approved under accelerated approval based on objective response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.