Arvinas announces submission of NDA to FDA for vepdegestrant

Arvinas (ARVN) (AZN) announced the submission of a New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA, with its partner Pfizer Inc. (PFE), for vepdegestrant for the treatment of patients with ER-positive/human epidermal growth factor receptor 2-negative ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. This submission is based on results from VERITAC-2, a global, randomized Phase 3 trial evaluating vepdegestrant versus fulvestrant. “This milestone comes after an exciting presentation at the American Society of Clinical Oncology’s annual meeting,” said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. “We look forward to the NDA review and to the first ever FDA-approved PROTAC ER degrader potentially being available to patients who could benefit from a much needed, new treatment option.”