Japanese firm Daiichi Sankyo Company, Limited has announced the launch of ENHERTU® (trastuzumab deruxtecan), a HER2 directed antibody drug conjugate (ADC), in Japan for the treatment of patients with HER2 positive unresectable or recurrent breast cancer after prior chemotherapy (limit the use to patients who are refractory or intolerant to standard treatments).

Marketing approval of ENHERTU by Japan’s Ministry of Health, Labor, and Welfare (MHLW) in March 2020 was based on the results of the open-label, single-arm, pivotal phase 2 DESTINY-Breast01 trial that demonstrated a confirmed objective response rate of 64.1% [95% CI: 56.3-71.3] in the response evaluable set of 107 of 167 patients, which included 26 Japanese women, at a data cut-off of March 21, 2019. Data from the DESTINY-Breast01 trial were published in The New England Journal of Medicine.

ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC Scientific platform.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, ENHERTU is comprised of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload by a tetrapeptide-based linker.