23 October 2023 - Approval based on DESTINY-Lung02 trial results where Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated a confirmed objective response rate of 49.0% and median duration of response of 16.8 months in previously treated patients.
Enhertu (trastuzumab deruxtecan) has been approved in the European Union as a monotherapy for the treatment of adult patients with advanced non-small-cell lung cancer whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.