CHMP Recommends EU Approval for Daiichi Sankyo’s Enhertu in Early Breast Cancer
Event summary
- CHMP recommends EU approval for Enhertu as adjuvant treatment for HER2+ early breast cancer with residual disease post-neoadjuvant therapy.
- DESTINY-Breast05 trial shows Enhertu reduces risk of invasive disease recurrence or death by 53% vs. T-DM1.
- European Commission to review recommendation for final marketing authorization.
- Enhertu already approved in Brazil, Canada, India, and the U.S. for the same indication.
The big picture
The CHMP recommendation for Enhertu underscores the growing role of antibody-drug conjugates in early-stage cancer treatment. Daiichi Sankyo and AstraZeneca’s collaboration continues to expand Enhertu’s indications, reinforcing its position as a key player in HER2-targeted therapies. The approval, if granted, would further solidify Enhertu’s market presence in adjuvant settings, competing directly with established treatments like T-DM1.
What we're watching
- Regulatory Timing
- The pace at which the European Commission grants final approval will determine Enhertu’s market entry timeline in the EU.
- Commercial Strategy
- How Daiichi Sankyo and AstraZeneca position Enhertu against existing adjuvant therapies in the EU.
- Clinical Adoption
- Whether oncologists rapidly adopt Enhertu given its proven efficacy in reducing recurrence risk.
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