EU CHMP recommends Enhertu plus Pertuzumab for 1L HER2 metastatic Breast cancer

CAR-T Digest - August 2020

Weekly Digest - July 2026

24 July 2026: EU CHMP recommends Enhertu plus Pertuzumab for 1L HER2 metastatic Breast cancer

AstraZeneca and Daiichi Sankyo announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Enhertu plus pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, marking the first potential new first-line treatment option in the EU in more than a decade
The recommendation is supported by the phase 3 DESTINY-Breast09 trial, where Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus taxane, trastuzumab and pertuzumab (PFS HR=0.56; p<0.00001), with a median progression-free survival of 40.7 months versus 26.9 months for THP and no new safety signals identified
The positive opinion has the potential to redefine the first-line treatment landscape for HER2-positive metastatic breast cancer by offering patients earlier access to a regimen that delivers substantially longer disease control than the current standard of care
Enhertu is a HER2-directed DXd antibody-drug conjugate that delivers a topoisomerase I inhibitor payload through a cleavable linker. In combination with pertuzumab, the regimen provides dual HER2 blockade alongside targeted intracellular payload delivery to enhance antitumor activity
Strategically, the positive CHMP opinion expands Enhertu’s use into the first-line metastatic setting in Europe, strengthens AstraZeneca and Daiichi Sankyo’s leadership in the HER2 ADC market, and supports their strategy of moving Enhertu earlier in the treatment pathway across HER2-positive breast cancer