Arvinas, Inc., in partnership with Pfizer, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant, a novel oral treatment for patients with estrogen receptor-positive (ER+)/HER2-negative, ESR1-mutated advanced or metastatic breast cancer. These patients must have previously received endocrine-based therapy.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2026.
Vepdegestrant is an investigational oral PROTAC ER degrader, designed to selectively target and degrade the estrogen receptor in cancer cells. The NDA is supported by data from the Phase 3 VERITAC-2 trial, which evaluated vepdegestrant against fulvestrant, the current standard of care. Results showed a significant improvement in progression-free survival, with a favorable safety profile. Full findings were recently presented at the ASCO 2025 Annual Meeting and published in The New England Journal of Medicine.
“Patients often face limited treatment options after first-line therapy,” said Dr. John Houston, CEO of Arvinas. “Vepdegestrant has shown encouraging efficacy and tolerability, and we believe it has the potential to become a best-in-class option for patients with ESR1-mutant breast cancer in the second-line setting.”
If approved, vepdegestrant would offer a new targeted therapy for a patient population with high unmet medical need, reinforcing the value of precision medicine in breast cancer treatment.