FDA approves VEPPANU, the first PROTAC therapy, for advanced ESR1-mutant breast cancer

The FDA has approved VEPPANU (vepdegestrant), developed by Arvinas and Pfizer, as the first PROTAC therapy for treating adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer after progression on endocrine therapy. VEPPANU demonstrated a 43% reduction in disease progression risk compared to fulvestrant in a Phase 3 trial, offering a new oral treatment option for patients with limited alternatives. Approval ahead of the June 5 deadline highlights its clinical impact, and Arvinas and Pfizer plan to select a third party to commercialize the drug soon.