Enhertu receives CHMP recommendation for adjuvant treatment of HER2-positive early Breast cancer

CAR-T Digest - August 2020

18 September 2026: Enhertu receives CHMP recommendation for adjuvant treatment of HER2-positive early Breast cancer

Daiichi Sankyo and AstraZeneca announced that Enhertu has been recommended by the EMA’s CHMP for EU approval as an adjuvant treatment for adults with resected HER2-positive early breast cancer who have residual invasive disease following neoadjuvant taxane-based and HER2-targeted therapy
The positive CHMP opinion is based on the phase 3 DESTINY-Breast05 trial, where Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 (HR=0.47), with 3-year invasive disease-free survival of 92.4% versus 83.7%
The recommendation addresses a major unmet need in HER2-positive early breast cancer with residual disease after neoadjuvant therapy, a high-risk population that remains vulnerable to recurrence despite current adjuvant treatment with T-DM1
Enhertu is a HER2-directed ADC comprising a HER2 monoclonal antibody linked to multiple topoisomerase I inhibitor DXd payloads through tetrapeptide-based cleavable linkers, while Datroway is a TROP2-directed DXd ADC designed to deliver the topoisomerase I inhibitor payload to TROP2-expressing tumor cells
Strategically, the CHMP recommendation would expand Enhertu further into the curative-intent early breast cancer setting in Europe, following its established role in metastatic disease and strengthening the ADC’s positioning across the HER2-positive treatment continuum