RegulatoryMay 26, 2026, 07:16 AM
AstraZeneca Enhertu Recommended for EU Approval in HER2+ Solid Tumors
AI Summary
AstraZeneca and Daiichi Sankyo's Enhertu has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for approval in the European Union. This recommendation is for Enhertu as a monotherapy to treat adult patients with previously treated unresectable or metastatic HER2-positive solid tumours who lack satisfactory treatment options. The positive opinion is based on clinically meaningful responses observed across a broad range of tumours in three Phase II trials: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02.
Key Highlights
- Enhertu recommended for EU approval by CHMP for HER2-positive metastatic solid tumours.
- Recommendation based on positive results from three Phase II trials: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02.
- DESTINY-PanTumor02 showed a 51.4% objective response rate (ORR) and 14.2 months median duration of response (DOR).
- DESTINY-Lung01 demonstrated a 52.9% ORR and 6.9 months median DOR in NSCLC patients.
- DESTINY-CRC02 showed a 46.9% ORR and 5.5 months median DOR in colorectal cancer patients.
- If approved, Enhertu would be the first HER2-directed therapy and antibody drug conjugate with a tumour agnostic indication in the EU.
- Enhertu already holds a tumour agnostic indication in the US and other countries.
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