ENHERTU, a HER2 directed a DXd antibody drug conjugate (ADC), was discovered by Daiichi Sankyo and is being jointly developed and commercialised by Daiichi Sankyo with AstraZeneca.
The EMA’s validation of the application signifies the commencement of a detailed scientific evaluation by its Committee for Medicinal Products for Human Use.
The application for ENHERTU is supported by data from the DESTINY-Breast06 Phase III trial, which was highlighted at the 2024 American Society of Clinical Oncology Annual Meeting.
Daiichi Sankyo global head for R&D Ken Takeshita said: “This submission builds on our existing indication for ENHERTU in patients with HER2 low metastatic breast cancer and an expanded approval would enable the potential for use in an earlier disease setting as well as in a broader patient population that now includes HER2 ultralow.”
For this indication, further regulatory submissions for ENHERTU are being pursued globally.
The DESTINY-Breast06 trial involved 866 patients across Asia, Europe, North America, Oceania, and South America, with 713 patients having HER2 low and 153 with HER2 ultralow breast cancer.
The DESTINY-Breast06 trial is a global, randomised, open-label Phase III study that compares the efficacy and safety of ENHERTU with the investigator’s choice of chemotherapy in patients with HR positive, HER2 low or ultralow advanced or metastatic breast cancer.
These patients had not received prior chemotherapy for advanced disease and had undergone at least two lines of endocrine therapy in the metastatic setting.