Arvinas, Inc. and Pfizer Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vepdegestrant. The application seeks approval for vepdegestrant as a treatment for patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer who have been previously treated with endocrine-based therapy.
This submission is supported by the positive results from the pivotal Phase 3 VERITAC-2 clinical trial, which demonstrated statistically significant and clinically meaningful improvement in progression-free survival in the ESR1-mutant population. The detailed results from VERITAC-2 were recently presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.
Vepdegestrant has already received Fast Track designation from the FDA as a monotherapy, underscoring the significant unmet medical need in this patient population. This NDA submission represents a major milestone, as vepdegestrant is a potential first-in-class investigational oral PROteolysis TArgeting Chimera (PROTAC) ER degrader.
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