Arvinas, Inc., in collaboration with Pfizer Inc., announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant. The NDA is for the treatment of patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer who have previously received endocrine-based therapy.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026, providing a clear timeline for a regulatory decision. This acceptance follows the positive results from the pivotal Phase 3 VERITAC-2 clinical trial, which demonstrated improved progression-free survival in the target patient population.
Vepdegestrant is the first PROteolysis TArgeting Chimera (PROTAC) to demonstrate clinical benefit in patients with breast cancer, and its NDA acceptance marks a significant milestone for the PROTAC platform. Arvinas believes vepdegestrant, if approved, has the potential to be a best-in-class treatment option in the second-line ESR1-mutant setting.
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