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FDA Grants Priority Review to Arvinas and Pfizer’s Breast Cancer Therapy

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Vepdegestrant PROTAC estrogen receptor degrader targets ER+ breast cancer with novel mechanism

The FDA accepted Arvinas and Pfizer’s New Drug Application for vepdegestrant (ARV-471), granting Priority Review for the novel PROTAC (proteolysis targeting chimera) therapy in estrogen receptor-positive breast cancer.

The innovative mechanism uses the body’s natural protein degradation system to eliminate estrogen receptors rather than simply blocking them, potentially overcoming resistance mechanisms that limit traditional hormone therapies.

Regulatory Timeline: Priority Review sets a target decision date by year-end 2025. If approved, vepdegestrant would represent the first PROTAC therapy to reach market, validating this emerging drug class for cancer treatment.

The collaboration combines Arvinas’ pioneering PROTAC platform with Pfizer’s oncology development and commercialization expertise, positioning the program for potential rapid market adoption following approval.

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