ENHERTU approved in the US for two new indications for patients with HER2-positive early Breast cancer

CAR-T Digest - August 2020

15 May 2026: ENHERTU approved in the US for two new indications for patients with HER2-positive early Breast cancer

ENHERTU received two new U.S. FDA approvals in HER2-positive early breast cancer, expanding its use into both neoadjuvant and adjuvant curative-intent settings and reinforcing its growing role across the full continuum of HER2-positive disease
The approvals were supported by the Phase 3 DESTINY-Breast11 and DESTINY-Breast05 trials, which demonstrated that ENHERTU could significantly improve outcomes both before surgery and after surgery in patients at high risk of recurrence
In DESTINY-Breast11, ENHERTU followed by THP achieved a pathologic complete response (pCR) rate of 67.3% compared with 56.3% for standard ddAC-THP, highlighting its potential to deepen responses in newly diagnosed Stage II/III HER2-positive early breast cancer
DESTINY-Breast05 showed that ENHERTU reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 in patients with residual invasive disease after neoadjuvant therapy, addressing a major unmet need in preventing progression to metastatic disease
With these approvals, AstraZeneca and Daiichi Sankyo continue to position ENHERTU as a foundational HER2-directed ADC, advancing its transition from metastatic treatment into earlier-stage breast cancer where the focus is increasingly on improving long-term cure outcomes