AstraZeneca (LSE:AZN) said the European Commission has approved Enhertu, its antibody-drug conjugate developed with Daiichi Sankyo, in combination with pertuzumab for first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer.
The approval follows the DESTINY-Breast09 Phase III trial, which showed the combination cut the risk of disease progression or death by 44% versus the existing standard of care, a taxane, trastuzumab and pertuzumab regimen.
Median progression-free survival reached 40.7 months on the Enhertu combination, against 26.9 months for the standard regimen, a gap researchers said could reshape first-line practice.
"The combination of trastuzumab deruxtecan and pertuzumab represents a significant therapeutic advance," said Cristina Saura of Vall d'Hebron University Hospital, a trial investigator, noting progression-free survival now exceeds three years against roughly two years under current standard care.
The approval triggers a $100 million milestone payment from AstraZeneca to Daiichi Sankyo under their March 2019 collaboration agreement, with most EU sales recognised by Daiichi Sankyo.
It marks the second new EU indication for Enhertu in two months, following a recent tumour-agnostic approval, and the drug's inclusion as a Category IA first-line option in ESMO's clinical practice guidelines.
Enhertu remains under EU review for a separate adjuvant indication based on the DESTINY-Breast05 trial.
News Intelligence what this means for the company
The European Commission has approved Enhertu (trastuzumab deruxtecan) combined with pertuzumab as first-line treatment for HER2-positive metastatic breast cancer, based on Phase III data showing a 44% reduction in disease progression or death risk and median progression-free survival of 40.7 months versus 26.9 months for the current standard regimen. The approval triggers a $100 million milestone payment to Daiichi Sankyo under their 2019 collaboration, and marks the second new EU indication for Enhertu in two months, positioning it as a Category IA option in ESMO guidelines.
This approval expands Enhertu's addressable market in a high-prevalence indication where the 14-month median PFS gain over current standard care could drive rapid uptake. The $100 million milestone is material relative to AstraZeneca's scale but signals Daiichi Sankyo's recognition of commercial potential; the company retains most EU sales rights, limiting upside to AstraZeneca's reported figures.
Insights assembled by AI. Editor-reviewed and grounded in tickstock’s coverage and proprietary knowledge graph.
Content is for informational purposes only, not financial advice.
