The U.S. Food and Drug Administration has accepted the New Drug Application submitted by Arvinas and its development partner Pfizer for vepdegestrant, an investigational oral PROTAC estrogen-receptor degrader intended for adults with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine therapy. The agency assigned a Prescription Drug User Fee Act action date of 5 June 2026 and granted the candidate Fast Track status. The filing is supported by results from the global Phase 3 VERITAC-2 study, in which vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in median progression-free survival versus fulvestrant. If approved, vepdegestrant would be the first PROTAC therapy to reach the market in breast cancer and would be co-commercialised by Arvinas and Pfizer under their 2021 collaboration agreement.