Arvinas and Pfizer Submit NDA for Vepdegestrant to FDA for Treatment of ESR1-Mutated ER+/HER2- Advanced Breast Cancer

Reuters
06-06
Arvinas and Pfizer Submit NDA for Vepdegestrant to FDA for Treatment of ESR1-Mutated ER+/HER2- Advanced Breast Cancer

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Arvinas Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9464423-en) on June 06, 2025, and is solely responsible for the information contained therein.

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