The FDA approved Arvinas’ first-in-class PROTAC Veppanu (vepdegestrant) for a defined subgroup of metastatic, estrogen receptor-positive, HER2-negative breast cancer patients whose disease progressed after at least one endocrine therapy and who have ESR1 mutations. The decision is tied to the VERITAC-2 trial results and is intended for a limited, biomarker-selected population. At the same time, the approval package includes Guardant Health’s CDx test, enabling treatment selection based on ESR1 status. In VERITAC-2, Arvinas reported that Veppanu improved progression-free survival by nearly three months versus fulvestrant. The marketing decision follows a narrower-than-expected differentiation narrative that has shaped investor expectations for Veppanu’s commercial reach, despite the regulatory milestone for targeted protein degradation in breast cancer.
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