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MAY 1 2026
APPROVED · 151 DAYS AGO

Arvinas — Veppanu (vepdegestrant) $ARVN

for ESR1-mutated ER+/HER2− advanced or metastatic breast cancer after prior endocrine therapy

NDA · Standard Review

FDA approved Veppanu (vepdegestrant) — the first PROTAC heterobifunctional protein degrader — for ESR1-mutated ER+/HER2− advanced breast cancer after prior endocrine therapy. Approval landed ~5 weeks ahead of the assigned PDUFA date. Pivotal data from VERITAC-2 vs. fulvestrant supported the filing.

About

Breast cancer driven by estrogen receptors can progress after initial hormone therapies, especially when the receptor itself acquires specific mutations. Vepdegestrant is a protein degrader that enters cells and tags the estrogen receptor for disposal by the cell's own waste-removal system. By eliminating the mutated receptor that fuels the cancer's growth, this drug may provide a new treatment path when prior therapies stop working.

Pivotal trial

VERITAC-2 Phase 3 active not recruiting NCT05654623

A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.

Source: ClinicalTrials.gov

Also in development