FDA approves vepdegestrant for ER positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer

FDA

1 May 2026 - Today, the FDA approved vepdegestrant (Veppanu, Arvinas), a heterobifunctional protein degrader, for adults with oestrogen receptor positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer, as detected by an FDA authorised test, with disease progression following at least one line of endocrine therapy.

FDA also approved the Guardant360 CDx as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with vepdegestrant.

Read FDA press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration