ENHERTU® Plus Pertuzumab Approved in the U.S. as First New First-Line Treatment in a Decade for HER2-Positive Metastatic Breast Cancer
Tuesday, December 16, 2025
AstraZeneca and Daiichi Sankyo have received U.S. approval for ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, confirmed by an FDA-approved test.
The approval follows Priority Review and Breakthrough Therapy Designation from the U.S. Food and Drug Administration and is based on results from the Phase III DESTINY-Breast09 trial. The findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine.
In the trial, ENHERTU plus pertuzumab significantly reduced the risk of disease progression or death compared with the current standard regimen of a taxane, trastuzumab and pertuzumab (THP). The combination lowered this risk by 44% and showed a median progression-free survival of 40.7 months, compared with 26.9 months for THP. Benefits were consistent across patient subgroups.
The safety profile of the combination matched the known profiles of the individual treatments, with no new safety concerns reported.
ENHERTU is a HER2-targeted antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialised with AstraZeneca. The application was reviewed under the FDA’s Real-Time Oncology Review programme and Project Orbis. Regulatory reviews are also ongoing in Switzerland, Singapore and other countries.
Source: businesswire.com
