CHMP Recommends EU Approval for Daiichi Sankyo’s Enhertu in HER2-Positive Solid Tumors
Event summary
- CHMP recommends EU approval for Enhertu as monotherapy for HER2-positive metastatic solid tumors.
- Approval based on phase 2 trial results showing ORR of 46.9%-52.9% across multiple tumor types.
- European Commission to review recommendation for final marketing authorization.
- Enhertu demonstrated clinically meaningful responses in DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 trials.
The big picture
This recommendation marks a strategic expansion for Enhertu beyond its established use in breast and gastric cancers, potentially unlocking a broader market in HER2-positive solid tumors. The approval reflects growing interest in precision oncology and antibody-drug conjugates (ADCs) as targeted cancer therapies. Daiichi Sankyo and AstraZeneca’s collaboration continues to drive Enhertu’s global development, positioning it as a key player in the oncology space.
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 HER2-targeted therapies in new tumor types.
- Clinical Expansion
- Whether additional trial data will support broader indications beyond HER2-positive (IHC 3+) tumors.
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