Pfizer's Vepdegestrant NDA Accepted by FDA for Breast Cancer Treatment, Potential for Growth in Oncology

The FDA has accepted Pfizer's New Drug Application for vepdegestrant, a potential treatment for certain breast cancer patients. This comes after Pfizer's share price rose by 10% in the last quarter, driven by strong earnings and positive product-related announcements. The FDA's acceptance is a positive development for Pfizer, which has faced challenges in the past year, including a 7.86% decline in total return and a projected revenue decline of 3% annually for the next three years. However, successful commercial execution and cost efficiencies could support Pfizer's growth trajectory and tighten the gap between its current valuation and analyst price targets.

The U.S. Food and Drug Administration (FDA) has accepted Pfizer's New Drug Application (NDA) for vepdegestrant, a potential treatment 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, for this 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].

Pfizer's share price rose by 10% in the last quarter, driven by strong earnings and positive product-related announcements. However, the company has faced challenges in the past year, including a 7.86% decline in total return and a projected revenue decline of 3% annually for the next three years. Successful commercial execution and cost efficiencies could support Pfizer's growth trajectory and tighten the gap between its current valuation and analyst price targets.

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