Enhertu now approved in Japan for gastric cancer

25 September 2020

Adding to the drug’s clearance for the treatment of patients with HER2 positive unresectable or recurrent breast cancer after prior chemotherapy in March, Japanese drugmaker Daiichi Sankyo (TYO: 4568) today announced the approval of Enhertu (trastuzumab deruxtecan), a HER2 directed antibody drug conjugate (ADC), in Japan for the treatment of patients with HER2 positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy.

Enhertu was previously granted SAKIGAKE designation by Japan’s Ministry of Health, Labor and Welfare (MHLW) for this indication.

Japan has the third highest incidence rate of gastric cancer worldwide, of which approximately one in five cases are considered HER2 positive. For patients with metastatic gastric cancer previously treated with two prior regimens including chemotherapy and an anti-HER2 therapy, Enhertu is the first and only HER2 directed medicine to demonstrate significant improvement in overall survival compared to chemotherapy.

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