Vepdegestrant FDA Approval Status
Last updated by Judith Stewart, BPharm on Aug 10, 2025.
FDA Approved: No
Generic name: vepdegestrant
Company: Arvinas, Inc.
Treatment for: Breast Cancer
Vepdegestrant is an orally bioavailable PROTAC protein degrader in development for the treatment of advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting.
- ESR1 mutations in breast cancer are a common cause of acquired resistance and are found in approximately 40% of patients in the second-line setting.
- Vepdegestrant is a PROTAC (PROteolysis TArgeting Chimera protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second line-plus setting.
- The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy.
- A New Drug Application (NDA) has been accepted by the FDA for vepdegestrant for the treatment of patients with ER+/HER2 ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. The NDA submission was based on results from VERITAC-2 (NCT05654623), a global, randomized Phase 3 trial evaluating vepdegestrant versus fulvestrant. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.
Development timeline for vepdegestrant
Further information
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