EMA validates application for trastuzumab deruxtecan (Enhertu) in HER2+ (IHC 3+) unresectable or metastatic solid tumors
On September 11th, 2025, Daiichi announced that the EMA validated the Type II Variation market authorization application for trastuzumab deruxtecan (Enhertu; HER2 ADC) in HER2+ (IHC 3+) unresectable or metastatic solid tumors who have received prior treatment and have no satisfactory alternative treatment options
The application is based on data from three P2 trials in which Enhertu showed “clinically meaningful benefit”: DESTINY-PanTumor02, DESTINY-CRC02, and DESTINY-Lung01
If approved, Enhertu would become the first HER2 directed therapy and ADC to receive a tumor agnostic indication in the EU
Enhertu was granted a tumor-agnostic HER2+ indication in the US based on data from these trials in Apr 2024 (accelerated approval)
AZ/Daiichi have also submitted an sNDA in Japan for this indication
AZ estimates HER2+ (IHC 3+) prevalence of 1-5% in NSCLC