The DESTINY-Breast05 phase 3 results show ENHERTU significantly reduces the risk of invasive disease recurrence or death vs. T-DM1, with a 53% lower risk (HR 0.47) and a three-year IDFS rate of 92.4% versus 83.7% for T-DM1.

Regulatory submissions for ENHERTU based on DESTINY-Breast05 are under review in the EU and Japan, with an additional U.S. sBLA for THP (paclitaxel, trastuzumab, pertuzumab) after neoadjuvant therapy, tied to DESTINY-Breast11 results and a May 18, 2026 PDUFA date.

Safety findings in DESTINY-Breast05 were in line with ENHERTU’s established profile, with no new safety concerns identified.

The sBLA is evaluated under Project Orbis to enable concurrent international review, accelerating access to effective cancer therapies.

ENHERTU has received FDA Priority Review for adults with HER2-positive breast cancer who have residual disease after neoadjuvant therapy, signaling potential earlier approval in the post-neoadjuvant setting; Breakthrough Therapy designation was granted in December 2025 based on DESTINY-Breast05.

ENHERTU is a HER2-directed antibody-drug conjugate (DXd) developed by Daiichi Sankyo and co-developed with AstraZeneca for commercial use.

DESTINY-Breast05 primary endpoint is investigator-assessed IDFS, with secondary endpoints including DFS, overall survival, DRFI, BMFI, and safety; investigators reported consistent benefits across prespecified subgroups.

The trial enrolled 1,635 patients across multiple regions and targeted individuals with high-risk residual disease after neoadjuvant therapy for post-neoadjuvant ENHERTU treatment.

Safety with ENHERTU in DESTINY-Breast05 aligns with its known profile; Grade 3+ treatment-emergent adverse events are similar to T-DM1, with notable events including neutropenia and decreases in neutrophils, WBCs, and platelets, and higher ILD/pneumonitis incidence in the ENHERTU arm.

Under Project Orbis, the sBLA allows simultaneous submission and review of oncology medicines across participating regions.

Subgroup analyses showed consistent results across prespecified groups, with ILD/pneumonitis and left ventricular dysfunction noted as safety considerations and monitored recommendations included.

EU and Japan regulatory reviews for ENHERTU are ongoing, with broader DESTINY program support (multiple trials) underpinning its development.