Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ERBB2 amplification status confers therapeutic sensitivity to Trastuzumab deruxtecan in patients with Non-Small Cell Lung Cancer.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.