Enhertu (T-DXd + THP) PDUFA Date (Daiichi Sankyo / AstraZeneca)
FDA PDUFA decision date for Enhertu (T-DXd + THP) is May 18, 2026. Developed by Daiichi Sankyo / AstraZeneca. Indication: HER2+ early breast cancer (neoadjuvant Stage II/III). Current status: Approved.
Indication
HER2+ early breast cancer (neoadjuvant Stage II/III)
Regulatory details
- Company: Daiichi Sankyo / AstraZeneca
- Therapeutic area: Oncology
- Application type: sBLA
- Review type: Standard
- PDUFA date: 2026-05-18
- Outcome: Approved