FDA Accepts Arvinas, Pfizer's Vepdegestrant NDA for Breast Cancer Treatment

Arvinas and Pfizer announce the FDA's acceptance of the new drug application for vepdegestrant, a treatment for estrogen receptor-positive/human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer. The FDA has assigned a Prescription Drug User Fee Act action date of June 5, 2026.

Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) have announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant, a novel treatment for estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-), ESR1-mutated advanced or metastatic breast cancer. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026 [1].

Vepdegestrant, an investigational oral PROteolysis TArgeting Chimera (PROTAC) ER degrader, demonstrated statistically significant and clinically meaningful improvement in median progression-free survival versus fulvestrant in the pivotal Phase 3 VERITAC-2 clinical trial [1]. This trial, which enrolled 624 patients, showed that vepdegestrant could extend the time before the cancer progresses compared to the standard of care, fulvestrant [1].

The acceptance of the NDA by the FDA marks a significant milestone in the development of vepdegestrant. The drug is being co-developed and co-commercialized by Arvinas and Pfizer, with both companies sharing the costs and potential profits [1]. The VERITAC-2 trial results were presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting and published in The New England Journal of Medicine [1].

Vepdegestrant is the first PROTAC to demonstrate clinical benefit in patients with breast cancer, offering a potential best-in-class treatment option for patients in the second-line ESR1-mutant setting [1]. The FDA's Fast Track designation underscores the significant unmet need in this patient population and the potential for vepdegestrant to offer a meaningful new treatment option [1].

The successful submission of the NDA and the upcoming PDUFA action date in June 2026 indicate a promising timeline for the approval of vepdegestrant. However, the approval process is subject to various risks and uncertainties, including the potential need for additional information or further studies by the FDA, as well as the ability to successfully commercialize the drug [1].

Arvinas and Pfizer are committed to working with the FDA to ensure that vepdegestrant is approved and made available to patients as rapidly as possible. The companies' collaboration and shared development costs reflect their commitment to advancing innovative treatments for patients with advanced or metastatic breast cancer [1].

References:
[1] https://finance.yahoo.com/news/arvinas-announces-fda-acceptance-drug-200500022.html