On 19 August, Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated a Type II Variation Application for the use of Enhertu® (trastuzumab deruxtecan) as a form of monotherapy treatment for individuals with unresectable or metastatic HER2 low or HER2 ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting. The application will now be considered by EMA’s Committee for Medicinal Products for Human Use (CHMP) and builds on the existing EU indication (approved January 2023) for patients with HER2 low metastatic breast cancer.
Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.
Enhertu® has previously been approved for HER2-low breast cancer in China (July 2023), Japan (March 2023) and the US (August 2022). On 29 July 2024, UK’s NICE (National Institute for Health and Care Excellence) released a statement that it will not recommend the use of trastuzumab deruxtecan for treatment of HER2-low breast cancer patients after chemotherapy in the NHS.