The European Commission’s approval follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use and is based on the Phase III DESTINY-Breast09 trial. In the study, Enhertu plus pertuzumab cut the risk of disease progression or death by 44% compared with the current standard of care (taxane, trastuzumab and pertuzumab), with median progression-free survival exceeding three years (40.7 months) versus 26.9 months on the standard regimen.

The approval is Enhertu’s second new EU indication in two months, following a recent tumour-agnostic approval. It also triggers a $100 million milestone payment from AstraZeneca to Daiichi Sankyo under their 2019 collaboration agreement. The combination has already been included in the ESMO Clinical Practice Guidelines as a Category IA first-line option.

“This approval brings Enhertu to patients in the EU earlier in the course of their metastatic disease and sets a new benchmark for progression-free survival in the first-line setting,” says Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit at AstraZeneca.