AstraZeneca and Daiichi Sankyo Receives Approval for Enhertu plus pertuzumab in HER2-positive Metastatic Breast Cancer
Tuesday, December 16, 2025
AstraZeneca and Daiichi Sankyo have received approval in the US for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer, as confirmed by an FDA-approved test, marking the first new first-line therapy in this setting in more than a decade.
Breast cancer is one of the most common cancers worldwide and a leading cause of cancer-related death. More than two million cases were diagnosed globally in 2022. In the US alone, over 300,000 people are diagnosed each year.
DESTINY-Breast09 is a global, randomised, open-label Phase III trial involving 1,157 patients across Africa, Asia, Europe, North America and South America. The study is evaluating Enhertu alone or in combination with pertuzumab against standard THP therapy as a first-line treatment.
Enhertu is a HER2-directed antibody-drug conjugate made up of a monoclonal antibody linked to a topoisomerase I inhibitor payload. It is the most advanced programme within Daiichi Sankyo’s oncology portfolio and a key part of AstraZeneca’s antibody-drug conjugate platform.
This marks the first approval in more than ten years of a new first-line treatment option for this patient group. The decision follows a Priority Review and Breakthrough Therapy Designation from the US Food and Drug Administration (FDA).
In DESTINY-Breast09, Enhertu plus pertuzumab showed a clear improvement in progression-free survival compared with the long-standing standard regimen of taxane, trastuzumab and pertuzumab (THP). The combination reduced the risk of disease progression or death by 44%. Median progression-free survival reached 40.7 months with Enhertu plus pertuzumab, compared with 26.9 months for THP. Benefits were consistent across patient subgroups.
The safety profile of the combination was in line with the known safety profiles of the individual treatments, with no new safety issues reported.
Regulatory reviews are ongoing in Switzerland and Singapore, with additional submissions under consideration in other countries.
Source: astrazeneca.com
