Clinical-stage biotechnology company Arvinas Inc (Nasdaq:ARVN) and biopharmaceutical company Pfizer Inc (NYSE:PFE) have submitted a New Drug Application to the US Food and Drug Administration (FDA) for vepdegestrant, an investigational treatment targeting estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) ESR1-mutated advanced or metastatic breast cancer, Arvinas announced on Friday.

The application focuses on patients who have previously received endocrine-based therapy.

The submission is supported by data from the Phase 3 VERITAC-2 trial, which compared vepdegestrant to fulvestrant. Results from the study were presented at the 2025 American Society for Clinical Oncology Annual Meeting and published in The New England Journal of Medicine.

Vepdegestrant is an oral PROTAC protein degrader designed to target and eliminate the estrogen receptor. The FDA has granted the therapy Fast Track designation as a monotherapy in this patient population.

Under a global collaboration established in 2021, Arvinas and Pfizer are jointly developing and will co-commercialize vepdegestrant, sharing development costs, commercialization expenses, and profits.