CHMP Recommends EU Approval for Daiichi Sankyo’s Enhertu-Pertuzumab Combo in HER2+ Breast Cancer
Event summary
- CHMP recommends approval of Enhertu® plus pertuzumab for first-line HER2+ metastatic breast cancer in the EU.
- DESTINY-Breast09 trial showed a 44% reduction in disease progression or death vs. standard therapy (THP).
- Median PFS extended to 40.7 months with Enhertu-pertuzumab combo, surpassing THP’s 26.9 months.
- European Commission review pending; approval would expand Enhertu’s EU footprint beyond existing indications.
The big picture
This recommendation solidifies Enhertu’s role in HER2-targeted therapies, expanding its reach beyond later-line treatments. The approval would mark a strategic shift toward earlier intervention in metastatic breast cancer, aligning with broader trends in precision oncology. Daiichi Sankyo and AstraZeneca are positioning Enhertu as a cornerstone of their ADC portfolios, competing directly with Roche’s established HER2-targeting regimens.
What we're watching
- Regulatory Timing
- The pace at which the European Commission grants final approval will determine Enhertu’s commercialization timeline in the EU.
- Market Penetration
- Whether Daiichi Sankyo and AstraZeneca can displace THP as the first-line standard of care for HER2+ metastatic breast cancer.
- Safety Monitoring
- How the safety profile, particularly interstitial lung disease risk, impacts real-world adoption of Enhertu-pertuzumab combo.
Related topics