FDA to Review Pfizer and Arvinas' Breast Cancer Therapy Vepdegestrant by June 5, 2026.

Arvinas and Pfizer's breast cancer therapy, vepdegestrant, has been accepted for review by the FDA for patients with advanced or metastatic breast cancer who have previously received endocrine-based therapy. The FDA has set a target action date of June 5, 2026. Vepdegestrant is being jointly developed by the two companies.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant, a novel therapy developed by Arvinas (Nasdaq: ARVN) and Pfizer (NYSE: PFE) for the treatment of patients with advanced or metastatic breast cancer who have previously received endocrine-based therapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026, marking a significant milestone in the development of this innovative breast cancer treatment [1].

Vepdegestrant is an investigational oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor degrader. It demonstrated statistically significant and clinically meaningful improvement in median progression-free survival (PFS) compared to fulvestrant in the pivotal Phase 3 VERITAC-2 clinical trial [1]. This trial, which enrolled 624 patients across 25 countries, showed that vepdegestrant can be a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second line-plus setting [1].

The FDA's acceptance of the NDA for vepdegestrant is significant because it is the first PROTAC to show clinical benefit in breast cancer patients. This innovative mechanism of action has the potential to offer a meaningful new treatment option for patients with ESR1-mutated ER+/HER2- advanced breast cancer, a challenging condition with limited second-line treatment options [2].

Arvinas and Pfizer are collaborating on the development and co-commercialization of vepdegestrant. The companies will share worldwide development costs, commercialization expenses, and profits. The FDA's Fast Track designation for vepdegestrant underscores the significant unmet need in this patient population [1].

The FDA's decision to accept the NDA for vepdegestrant represents a significant advancement toward potential approval by June 2026. The companies are now working with the FDA to pursue vepdegestrant's approval and ensure this important treatment option is made available to patients as rapidly as possible [1].

References:
[1] https://finance.yahoo.com/news/arvinas-announces-fda-acceptance-drug-200500022.html
[2] https://www.stocktitan.net/news/ARVN/arvinas-announces-fda-acceptance-of-the-new-drug-application-for-okkkur95p9p1.html