Enhertu + Pertuzumab (T-DXd) PDUFA Date (Daiichi Sankyo / AstraZeneca)
FDA PDUFA decision date for Enhertu + Pertuzumab (T-DXd) is January 17, 2026. Developed by Daiichi Sankyo / AstraZeneca. Indication: HER2+ metastatic breast cancer (first-line). Current status: Approved.
Indication
HER2+ metastatic breast cancer (first-line)
Regulatory details
- Company: Daiichi Sankyo / AstraZeneca
- Therapeutic area: Oncology
- Application type: sBLA
- Review type: Priority
- PDUFA date: 2026-01-17
- Outcome: Approved