Arvinas Receives FDA Approval for VEPPANU (vepdegestrant) in ESR1-mutated Advanced Breast Cancer

On May 1, 2026, Arvinas, Inc. announced that the FDA granted approval for VEPPANU™ (vepdegestrant) for the treatment of adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer following at least one line of endocrine-based therapy. This marks the first-ever FDA approval of a PROteolysis Targeting Chimera (PROTAC) protein degrader. The approval was based on the Phase 3 VERITAC-2 trial, where vepdegestrant demonstrated a 43% reduction in the risk of disease progression or death compared to fulvestrant, with a median PFS of 5 months versus 2.1 months (p=0.0001). The approval came ahead of the June 5, 2026, PDUFA date. As a result of this milestone, Arvinas will receive a $50 million development milestone payment from its collaborator, Pfizer Inc., subject to offsets for amounts owed to Yale University. Arvinas and Pfizer remain on track to select a third-party partner to commercialize the therapy. Common side effects included decreased white blood cell counts and increased liver function tests.