USFDAMay 1, 2026, 01:24 PM
Arvinas & Pfizer Receive FDA Approval for VEPPANU, First PROTAC Therapy
AI Summary
Arvinas, Inc., with its partner Pfizer Inc., announced that the U.S. Food and Drug Administration (FDA) has approved VEPPANU (vepdegestrant) for the treatment of adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. This marks the first FDA approval of a PROteolysis TArgeting Chimera (PROTAC) therapy, a new class of protein degraders. The approval was received ahead of the June 5, 2026 PDUFA date, and the companies plan to select a third-party partner for commercialization.
Key Highlights
- FDA approved VEPPANU (vepdegestrant) for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer.
- VEPPANU is the first-and-only FDA-approved PROTAC (PROteolysis TArgeting Chimera) therapy.
- Approval was granted ahead of the FDA-assigned PDUFA date of June 5, 2026.
- VEPPANU targets ESR1-mutated breast cancer, addressing a significant unmet medical need.
- In the VERITAC-2 trial, vepdegestrant reduced the risk of disease progression or death by 43% vs. fulvestrant.
- Median progression-free survival (PFS) was 5 months for vepdegestrant vs. 2.1 months for fulvestrant.
- Arvinas and Pfizer will jointly select a third-party partner for VEPPANU's commercialization.