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 treatment for estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer. The FDA has set a target action date of June 5, 2026, for the Prescription Drug User Fee Act (PDUFA) review [1].

Vepdegestrant, an investigational oral PROteolysis TArgeting Chimera (PROTAC) ER degrader, is being jointly developed by Arvinas (NASDAQ: ARVN) and Pfizer Inc. (NYSE: PFE). The NDA submission was based on data from the Phase 3 VERITAC-2 clinical trial, which demonstrated significant improvement in progression-free survival (PFS) compared to fulvestrant, the current standard treatment [1].

The VERITAC-2 trial, presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting and published in The New England Journal of Medicine, enrolled 624 patients and showed that 43% of patients had ESR1 mutations. The primary endpoint was PFS in the ESR1-mutation and intent-to-treat populations [1].

Vepdegestrant is the first PROTAC to show clinical benefit in breast cancer patients. Unlike traditional inhibitors, PROTACs work by tagging specific disease-causing proteins for degradation by the cell's own waste disposal system, potentially offering more complete and durable protein elimination [1].

The FDA's acceptance of Arvinas and Pfizer's NDA for vepdegestrant represents a significant milestone in breast cancer treatment. This novel therapy targets ESR1-mutated ER+/HER2- advanced breast cancer, a challenging condition with limited second-line treatment options. The favorable tolerability profile and efficacy data suggest vepdegestrant could become a preferred second-line therapy option for patients with ESR1 mutations [1].

The simultaneous publication in The New England Journal of Medicine and presentation at ASCO underscores the medical significance of these findings and provides additional validation of the clinical data supporting this application [1].

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