ENHERTU supplemental New Drug Application submitted in Japan for patients with HER2 positive metastatic Solid tumors

CAR-T Digest - August 2020

24 Apr 2025: ENHERTU supplemental New Drug Application submitted in Japan for patients with HER2 positive metastatic Solid tumors

Daiichi Sankyo has submitted a supplemental New Drug Application in Japan for ENHERTU to treat adult patients with HER2 positive advanced or recurrent solid tumors unresponsive to standard treatments
The submission is supported by data from four Phase 2 trials—HERALD, DESTINY-PanTumor02, DESTINY-CRC02, and DESTINY-Lung01—that showed clinically meaningful responses across various tumor types
If approved, ENHERTU could become the first HER2-directed therapy and antibody-drug conjugate in Japan with a tumor-agnostic indication
Currently, HER2 therapies in Japan are only approved for certain cancers like breast, colorectal, gastric, lung, and salivary gland, with no options for other HER2 overexpressed or amplified cancers
Daiichi Sankyo aims to expand treatment access and improve outcomes for patients with diverse HER2 positive metastatic solid tumors through this new approval