On 16 September 2026, Daiichi Sankyo announced that Japan’s Ministry of Health, Labour and Welfare has approved Enhertu® (trastuzumab deruxtecan) and Datroway® (datopotamab deruxtecan) for two new breast cancer indications. Enhertu®, in combination with pertuzumab (Roche’s Perjeta®) was approved for the treatment of adults with HER2 positive unresectable or recurrent breast cancer, while Datroway® was approved for adults with hormone receptor negative and HER2 negative unresectable or recurrent breast cancer.
The same new indication for Enhertu® was recently approved in Europe and was approved by the FDA in December 2025. These are the first new regimens in more than a decade to be approved in for the first line treatment of HER2 positive breast cancer.
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu® in March 2019 and Datroway® in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each product. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu® and Datroway®.
Biosimilars of Enhertu® are under development. Samsung Bioepis has a trastuzumab deruxtecan biosimilar in its pipeline, while Shanghai Henlius and Organon are leading the pertuzumab biosimilar race in major markets, with approvals of Poherdy® (pertuzumab) secured in the US (November 2025), EU (April 2026), and China (as Hanbeiyou®, May 2026). Roche/Genentech are currently suing Biocon in the US in relation to biosimilar pertuzumab (Bmab 1500).