ARVN · Arvinas, Inc.

On May 1, 2026, Arvinas announced FDA approval of VEPPANU (vepdegestrant) for adults with ER+/HER2- ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy. This is the first FDA-approved PROTAC therapy, validating Arvinas' protein degradation platform. Approval was granted ahead of the June 5, 2026 PDUFA date. The approval triggers a $50 million milestone payment from Pfizer under their collaboration agreement, partially offset by payments to Yale University. Arvinas and Pfizer plan to select a third-party commercial partner. The Phase 3 VERITAC-2 trial demonstrated a 43% reduction in risk of progression or death versus fulvestrant. This approval addresses a significant unmet need in ESR1-mutated breast cancer, where resistance to endocrine therapy is common.