ENHERTU Supplemental New Drug Application submitted in Japan as adjuvant therapy for patients with HER2 positive early breast cancer

CAR-T Digest - August 2020

Weekly Digest - March 2026

27 February 2026: ENHERTU Supplemental New Drug Application submitted in Japan as adjuvant therapy for patients with HER2 positive early breast cancer

Daiichi Sankyo has taken a new step to expand the role of its blockbuster ADC Enhertu, submitting a supplemental New Drug Application to Japan’s Ministry of Health, Labour and Welfare to use the therapy as an adjuvant treatment for patients with HER2-positive early breast cancer who still have residual invasive disease after neoadjuvant therapy
The submission builds on strong clinical evidence, as results from the DESTINY-Breast05 trial showed that ENHERTU significantly improved invasive disease-free survival compared with trastuzumab emtansine (T-DM1), reducing the risk of invasive disease recurrence or death by 53% in this high-risk patient population
These findings have fueled expectations that ENHERTU could reshape treatment in this setting, with the ADC designed to precisely target HER2 and deliver its DXd payload potentially emerging as a new standard of care for patients with HER2-positive early breast cancer who do not achieve complete response after pre-surgery therapy
The regulatory filing also reflects Daiichi Sankyo’s broader strategy to expand ENHERTU into earlier lines of therapy, reinforcing the company’s commitment to bringing the drug into curative-intent settings where preventing recurrence can significantly improve long-term outcomes
Beyond Japan, the momentum around ENHERTU continues globally, as the therapy has already received BTD from the U.S. Food and Drug Administration based on DESTINY-Breast05 results, while additional regulatory submissions and studies including DESTINY-Breast09 trial and DESTINY-PanTumor02 trial are underway to broaden its use across multiple HER2-driven cancers