ENHERTU approved in Japan as first tumor agnostic HER2 directed medicine for previously treated patients with HER2 positive metastatic solid tumors

CAR-T Digest - August 2020

Weekly Digest - March 2026

23 March 2026: ENHERTU approved in Japan as first tumor agnostic HER2 directed medicine for previously treated patients with HER2 positive metastatic solid tumors

Japan’s MHLW has approved ENHERTU for previously treated HER2-positive advanced solid tumors, marking the first tumor-agnostic approval for a HER2-directed therapy and ADC in Japan
The decision is based on results from multiple Phase II trials, including HERALD, DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02, where ENHERTU demonstrated consistent clinical activity across a wide range of HER2-positive solid tumors
Across these studies, ENHERTU showed clinically meaningful response rates ranging from approximately 47% to 61%, with a 56.5% response in HERALD, 61.3% in DESTINY-PanTumor02, 52.9% in DESTINY-Lung01, and 46.9% in DESTINY-CRC02, highlighting broad antitumor efficacy
The safety profile remained consistent with previous experience, with common adverse events such as nausea, fatigue, and hematologic toxicities, while interstitial lung disease (ILD) continues to be an important risk requiring careful monitoring in clinical practice
This approval reflects a broader shift toward biomarker-driven oncology, where HER2 expression is used to guide treatment decisions across multiple tumor types rather than limiting therapy to a single cancer type