WILMINGTON, DE — AstraZeneca PLC (NASDAQ: AZN) and Japan’s Daiichi Sankyo said the U.S. Food and Drug Administration has approved ENHERTU in combination with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, marking the most significant advance in this setting in more than a decade.
The approval follows Priority Review and Breakthrough Therapy Designation and is based on results from the Phase III DESTINY-Breast09 trial, which showed the ENHERTU combination cut the risk of disease progression or death by 44% compared with the current standard regimen of taxane, trastuzumab, and pertuzumab. Median progression-free survival reached 40.7 months, exceeding three years, versus 26.9 months for the standard therapy.
Trial results were presented earlier this year at the American Society of Clinical Oncology annual meeting and published in The New England Journal of Medicine. Investigators reported consistent benefit across patient subgroups, with no new safety concerns beyond the known profiles of the individual therapies.
Sara Tolaney, chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and principal investigator for the trial, said the ENHERTU and pertuzumab combination is the first first-line regimen in more than 10 years to deliver a statistically significant improvement in progression-free survival over existing standards for patients with HER2-positive metastatic breast cancer.
AstraZeneca said the approval brings ENHERTU into the earliest treatment setting for this patient population, where gains in disease control can have a meaningful impact on long-term outcomes. Daiichi Sankyo said the decision reinforces ENHERTU’s role as a practice-changing therapy, building on its earlier approvals in later lines of treatment.
ENHERTU is a HER2-directed antibody-drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca. The FDA review was conducted under the agency’s Real-Time Oncology Review program and Project Orbis, which allows for coordinated international regulatory assessments. The regimen is currently under review by regulators in Switzerland and Singapore, with additional applications pending in other countries.
The approval also carries financial implications for the partners. AstraZeneca will make a $150 million milestone payment to Daiichi Sankyo tied to the first-line indication. Under the companies’ collaboration agreement, Daiichi Sankyo recognizes U.S. sales of ENHERTU.
The decision reshapes the treatment landscape for HER2-positive metastatic breast cancer and sets a new benchmark for first-line therapy, as regulators and clinicians increasingly prioritize regimens that deliver longer disease control earlier in the course of care.
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