On February 12, 2026, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration announced on February 4 that ENHERTU® (trastuzumab deruxtecan) has been proposed for inclusion in the Breakthrough Therapy Program for use as adjuvant therapy in adult patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant anti-HER2 therapy. This decision is based on compelling data from the DESTINY-Breast05 Phase III study, presented at the 2025 ESMO Congress, which demonstrated that ENHERTU reduced the risk of invasive disease-free survival (IDFS) events or death by 53% compared to T-DM1.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
DESTINY-Breast05 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus trastuzumab emtansine (T-DM1) in patients with HER2 positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.
Key data from the DESTINY-Breast05 study:
- Invasive Disease-Free Survival (IDFS): The three-year IDFS rate was 92.4% in the ENHERTU arm versus 83.7% in the control arm (T-DM1), representing a 53% reduction in risk (HR=0.47).
- Disease-Free Survival (DFS): The three-year DFS rate was 92.3% in the ENHERTU arm versus 83.5% in the control arm, also reflecting a 53% risk reduction (HR=0.47).
- Distant Recurrence Risk (DRFI): Reduced by 51%, with three-year DRFI rates of 93.9% vs. 86.1%.
- Brain Metastasis Risk (BMFI): Reduced by 36%, with three-year BMFI rates of 97.6% vs. 95.8%.
The International Department of Beijing Southern Suburb Cancer Hospital is dedicated to serving overseas patients, offering multilingual support, direct billing with international insurance, personalized patient accompaniment, and teleconsultation services. For patients with HER2-positive breast cancer, the International Department provides a multidisciplinary team of senior oncologists to develop individualized adjuvant treatment plans.
Consult now for a treatment assessment:
International Patient Hotline: 400-880-3716 (24-hour bilingual service, Chinese/English)
WeChat Direct Line: 17801183037
Official Email ①: 100085_010@163.com
Backup Email ②: myimmnet@163.com
Whether you are a newly diagnosed patient seeking strategies for residual disease after neoadjuvant therapy, or a patient who has undergone surgery and is considering an escalated adjuvant treatment plan, the International Department team can complete a preliminary medical record review promptly and provide written treatment recommendations.
Post time: Feb-12-2026