Arvinas Inc., in collaboration with Pfizer, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vepdegestrant, a potential new treatment for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer. This submission, announced on June 6, 2025, is supported by positive results from the pivotal Phase 3 VERITAC-2 clinical trial, which were recently highlighted at the 2025 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine. Vepdegestrant, which has been granted fast track designation as a monotherapy, represents a potential first-ever FDA-approved PROTAC ER degrader for this patient population. Arvinas and Pfizer's joint development highlights a significant milestone in bringing a much-needed treatment option closer to availability for patients.
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