SWB:D4S

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Daiichi Sankyo announced that ENHERTU (trastuzumab deruxtecan) has been approved in Japan as the first tumor-agnostic HER2-directed therapy for patients with previously treated HER2-positive metastatic solid tumors.

The approval by Japan’s Ministry of Health is based on results from four phase 2 trials, where the drug demonstrated clinically meaningful response rates across multiple tumor types, including lung, colorectal, and gynecological cancers.

This milestone expands ENHERTU’s use to six indications in Japan and highlights the growing role of HER2 testing across a wide range of cancers, although the treatment carries known safety risks such as interstitial lung disease requiring close monitoring.
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Author
European Investor 03-23-26