regulatory
confidence high
sentiment positive
materiality 0.95
Arvinas gets FDA approval for VEPPANU (vepdegestrant) in ESR1m breast cancer; first PROTAC approved
ARVINAS, INC.
- FDA approved VEPPANU for ER+/HER2-, ESR1-mutated advanced/metastatic breast cancer after at least one prior endocrine therapy.
- VEPPANU is the first FDA-approved PROTAC degrader; approval came before June 5, 2026 PDUFA date.
- Arvinas to receive $50M development milestone payment from collaborator Pfizer upon approval.
- Arvinas and Pfizer on track to select third-party for VEPPANU commercialization.
- Phase 3 VERITAC-2: vepdegestrant reduced risk of progression or death by 43% vs fulvestrant (HR 0.57, p=0.0001).