Vepdegestrant (ARV-471) PDUFA Date (Arvinas / Pfizer)
FDA PDUFA decision date for Vepdegestrant (ARV-471) is June 5, 2026. Developed by Arvinas / Pfizer. Indication: ESR1-mutated ER+/HER2- advanced breast cancer. Current status: Approved.
Indication
ESR1-mutated ER+/HER2- advanced breast cancer
Notes
First-in-class protein degrader (PROTAC). Potential blockbuster in breast cancer.
Regulatory details
- Company: Arvinas / Pfizer
- Therapeutic area: Oncology
- Application type: NDA
- Review type: Fast Track
- PDUFA date: 2026-06-05
- Outcome: Approved