ENHERTU Type II variation application validated in the EU for previously treated patients with HER2 positive metastatic solid tumors

CAR-T Digest - August 2020

Weekly Digest - September 2025

11 September 2025: ENHERTU Type II variation application validated in the EU for previously treated patients with HER2 positive metastatic solid tumors

The EMA has validated a Type II Variation application for ENHERTU (trastuzumab deruxtecan) to treat adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) solid tumors lacking satisfactory alternatives
The submission is supported by data from three Phase 2 studies (DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01) showing clinically meaningful responses across a wide range of tumor types
If approved, ENHERTU would be the first HER2-directed therapy and ADC to receive a tumor-agnostic indication in the EU
Validation by EMA confirms the application is complete and starts the CHMP scientific review, which Daiichi Sankyo views as a key step toward bringing this medicine to more patients