FDA accepts Arvinas drug application for advanced breast cancer treatment

The U.S. Food and Drug Administration has accepted Arvinas Inc.'s (NASDAQ: ARVN) new drug application for vepdegestrant, a treatment for patients with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer who have previously received endocrine-based therapy.

The FDA assigned a Prescription Drug User Fee Act action date of June 5, 2026, for the application submitted jointly with partner Pfizer Inc. (NYSE: PFE). The submission was based on data from the Phase 3 VERITAC-2 clinical trial, which demonstrated improved progression-free survival compared to fulvestrant in patients with ESR1-mutated breast cancer.

Vepdegestrant is an oral PROTAC estrogen receptor degrader being developed through a collaboration between Arvinas and Pfizer. The companies share worldwide development costs, commercialization expenses, and profits under their July 2021 agreement.

The VERITAC-2 trial enrolled 624 patients at 213 sites across 25 countries, with 270 patients having ESR1-positive disease. Patients were randomized to receive either vepdegestrant once daily orally or fulvestrant administered intramuscularly. The primary endpoint measured progression-free survival in both ESR1-mutation and intent-to-treat populations.

The drug has received Fast Track designation from the FDA, which is granted to treatments addressing significant unmet medical needs. Trial data were presented at the American Society of Clinical Oncology 2025 Annual Meeting and published in The New England Journal of Medicine.

"Patients often face limited treatment options after first-line treatment and vepdegestrant demonstrated improved progression-free survival in patients with ESR1-mutated ER+/HER2- advanced breast cancer," said John Houston, CEO and President at Arvinas.

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