NEW YORK CITY (dpa-AFX) - Arvinas (ARVN) announced the submission of a New Drug Application to the FDA with its partner Pfizer (PFE), for vepdegestrant for the treatment of patients with ER+/human epidermal growth factor receptor 2-negative ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. The submission is based on results from VERITAC-2, a global, randomized Phase 3 trial evaluating vepdegestrant versus fulvestrant.
Vepdegestrant is being jointly developed by Arvinas and Pfizer for the treatment of patients with advanced or metastatic ER+/HER2- breast cancer and was granted fast track designation as a monotherapy by the FDA.
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