AstraZeneca, Daiichi Sankyo win EU approval for Enhertu, first regimen in decade

The European Commission approved AstraZeneca and Daiichi Sankyo’s Enhertu, combined with pertuzumab, for first-line treatment of unresectable or metastatic HER2-positive breast cancer. This marks the first new regimen approved for this patient group in the EU in over a decade. The approval positions the therapy as a potential new standard of care.

Results from the pivotal Phase III DESTINY-Breast09 trial supported the approval. The Enhertu combination reduced the risk of disease progression or death by 44% compared to the current standard therapy.

The trial demonstrated a median progression-free survival of 40.7 months for the Enhertu regimen. The current standard of care recorded a median progression-free survival of 26.9 months. AstraZeneca will make a $100 million milestone payment to Daiichi Sankyo following the approval.