Arvinas Submits NDA To FDA With Partner Pfizer For Vepdegestrant For Treatment Of Patients With ER+/HER2- ESR1-Mutated Advanced Or Metastatic Breast Cancer Previously Treated With Endocrine-Based Therapy

– This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and published in The New England Journal of Medicine –

– VERITAC-2 data support vepdegestrant as a potential treatment option in patients with ESR1m ER+/HER2- advanced or metastatic breast cancer –

NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with its partner Pfizer Inc. (NYSE:PFE), for vepdegestrant for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. This submission is based on results from VERITAC-2 (NCT05654623), a global, randomized Phase 3 trial evaluating vepdegestrant versus fulvestrant.