Posted by Michael Wonder on 06 May 2026
Guardant Health receives FDA approval for Guardant360 CDx as a companion diagnostic for Arvinas and Pfizer’s Veppanu (vepdegestrant) for patients with ER+/HER2- advanced breast cancer with ESR1 mutations
4 May 2026 - Guardant Health today announced that the US FDA has approved the Guardant360 CDx liquid biopsy test as a companion diagnostic for Veppanu (vepdegestrant).
Veppanu, jointly developed by Arvinas and Pfizer, is approved for the treatment of adults with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, oestrogen receptor 1-mutated advanced or metastatic breast cancer, as detected by an FDA authorised test, with disease progression following at least one line of endocrine therapy.
