ARVN
Vepdegestrant (ARV-471)
FDA PDUFA Target Action Date · Arvinas, Inc.
Friday, June 5, 2026
Approved
approved Note: Approved 2026-05-01 as VEPPANU (ORIG NDA219835). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 35d from the PDUFA date. MEDIUM match accepted by owner review 2026-10-06: it is the drug's first-ever (ORIG) approval, so it can only be this decision.
Drug Information
- Drug Name
- Vepdegestrant (ARV-471) (CT.gov)
- Application Type
- NDA
- FDA Designations
- Fast Track
- Indication
- ESR1-mutated, ER+/HER2- advanced/metastatic breast cancer (post-endocrine therapy)
- Approved As
- Vepdegestrant (ARV-471)
Filing Details
- Company
- Arvinas, Inc.
- Stock Ticker
- ARVN
- SEC CIK
- 0001655759
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-04-10. Report an issue