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MAY 1 2026
APPROVED · 91 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

Veppanu treats a form of advanced breast cancer where tumor growth is driven by the estrogen receptor, a common target for therapy. It works by physically tagging the estrogen receptor protein inside a cell and escorting it to the cell's natural disposal system for destruction. This "tag-and-trash" mechanism, which goes beyond just blocking the receptor, may provide a more durable way to stop cancer growth in patients whose disease has progressed on prior treatments.

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