Enhertu plus pertuzumab approved in the EU for the 1st-line treatment of patients with HER2-positive metastatic Breast cancer

CAR-T Digest - August 2020

01 September 2026: Enhertu plus pertuzumab approved in the EU for the 1st-line treatment of patients with HER2-positive metastatic Breast cancer

Daiichi Sankyo and AstraZeneca announced that Enhertu plus pertuzumab has been approved in the EU for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, establishing the first new first-line regimen in more than a decade
The approval is based on the phase 3 DESTINY-Breast09 study, where Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus taxane, trastuzumab and pertuzumab (THP) (HR=0.56), with median PFS of 40.7 months versus 26.9 months and confirmed ORR of 85.1% versus 78.6%
The approval addresses a major unmet need in HER2-positive metastatic breast cancer, where the current THP standard has been used for more than a decade and most patients experience disease progression within two years of first-line treatment
Enhertu is a HER2-directed ADC comprising a HER2 monoclonal antibody linked to multiple topoisomerase I inhibitor DXd payloads through tetrapeptide-based cleavable linkers, enabling targeted delivery of the cytotoxic payload to HER2-expressing tumor cells
Strategically, the EU approval moves Enhertu plus pertuzumab into the earlier first-line metastatic setting, with more than three years of median PFS establishing a new benchmark and strengthening Daiichi Sankyo and AstraZeneca’s leadership in HER2-directed ADC therapy