Arvinas, Pfizer’s Vepdegestrant NDA Accepted by FDA for Breast Cancer Treatment

Arvinas Inc. (NASDAQ:ARVN) is one of the best small cap stocks with biggest upside potential. On August 8, Arvinas, in collaboration with Pfizer Inc. (NYSE:PFE), announced that the US FDA accepted its New Drug Application/NDA for vepdegestrant. The drug is intended to treat patients with estrogen receptor-positive/ER+, human epidermal growth factor receptor 2-negative/HER2-, ESR1-mutated advanced or metastatic breast cancer who have already received endocrine-based therapy.

The FDA has set a Prescription Drug User Fee Act/PDUFA action date of June 5, 2026. The NDA is based on data from the Phase 3 VERITAC-2 clinical trial, which showed a statistically significant and clinically meaningful improvement in median progression-free survival for vepdegestrant compared to fulvestrant. The trial enrolled 624 patients at 213 sites across 25 countries, with 270 of these patients having the ESR1 mutation.

A biopharma executive in a meeting room discussing the clinical-stage of a new therapy.

The results from this trial were recently presented at the American Society of Clinical Oncology/ASCO 2025 Annual Meeting and published in The New England Journal of Medicine. Vepdegestrant is an investigational oral drug that functions as a PROteolysis TArgeting Chimera/PROTAC estrogen receptor degrader. This marks the first time a PROTAC has demonstrated a clinical benefit in breast cancer patients.

Arvinas Inc. (NASDAQ:ARVN) is a clinical-stage biotechnology company that engages in the discovery, development, and commercialization of therapies to degrade disease-causing proteins.

Pfizer Inc. (NYSE:PFE) discovers, develops, manufactures, markets, distributes, and sells biopharmaceutical products in the US and internationally.

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Disclosure: None. This article is originally published at Insider Monkey.