New Breast Cancer Treatment
European Union approves Enhertu combination therapy for first-line breast cancer treatment.
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Key Points
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DESTINY-Breast09 enrolled a global, multicenter cohort of 1,157 patients and showed a hazard ratio for progression-free survival of 0.56 (a 44% reduction in risk) with the Enhertu plus pertuzumab combination, yielding a median PFS of 40.7 months versus 26.9 months with THP.
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The pivotal trial population included adults with unresectable or metastatic HER2-positive breast cancer who had not received prior chemotherapy or HER2-targeted therapy, or who had such therapy more than six months earlier in the adjuvant/neoadjuvant setting.
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The European Medicines Agency’s approval was based on DESTINY-Breast09 results and was integrated into European guidelines, with the regimen adopted into ESMO guidelines to potentially accelerate European uptake.
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EU approval followed a positive CHMP opinion and the DESTINY-Breast09 data were published in The New England Journal of Medicine, with the results first presented at the 2025 ASCO meeting.
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Daiichi Sankyo retains responsibility for manufacturing and supply of Enhertu in the EU post-approval, reflecting the ongoing manufacturing role within the collaboration.
The European Union has approved Enhertu plus pertuzumab as first-line treatment for adults with advanced HER2-positive breast cancer, according to Nasdaq. The combination drug reduced the risk of disease progression or death by 44% in a major trial, extending median progression-free survival to 40.7 months compared to 26.9 months with the previous standard treatment.
This marks the first new first-line regimen for this aggressive cancer type in more than a decade, Graifa reported. AstraZeneca will pay Daiichi Sankyo a $100 million milestone payment upon the approval, highlighting the strategic importance of the partnership.
DESTINY-Breast09 Trial Delivered 44% Risk Reduction
The DESTINY-Breast09 trial enrolled 1,157 patients globally with unresectable or metastatic HER2-positive breast cancer. The Enhertu-pertuzumab combination achieved a hazard ratio of 0.56 for progression-free survival, according to Mirage News, translating to a 44% reduction in disease progression or death risk.
Patients on the new combo reached a median progression-free survival of 40.7 months versus 26.9 months with standard THP chemotherapy and HER2-targeted therapy. The trial included patients who had never received prior chemotherapy or HER2 drugs, or who had stopped such therapy at least six months earlier.
Why This Matters for Breast Cancer Care
Doctors can now offer a highly effective option earlier in treatment. Starting powerful HER2-directed therapy at the first sign of advanced disease means patients could live longer before their cancer worsens. The previous standard has been the benchmark for years, so this approval represents a meaningful shift in European oncology practice.
Medical guidelines have already incorporated this regimen into treatment recommendations. The European Society for Medical Oncology (ESMO) updated its guidance to include the Enhertu-pertuzumab combo, signaling confidence in the results and positioning it as a preferred first-line choice across Europe.
AstraZeneca and Daiichi Sankyo Partnership Strengthened
The $100 million milestone payment underscores the commercial value of the collaboration between the two pharmaceutical companies. AstraZeneca is responsible for marketing while Daiichi Sankyo continues to manufacture and supply Enhertu across the EU after approval.
The DESTINY-Breast09 data were published in The New England Journal of Medicine and presented at the 2025 ASCO medical conference. The European Medicines Agency based its approval decision on these rigorous clinical results, with no new safety concerns identified in the trial.
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