Business
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
PALO ALTO, Calif., May 04, 2026--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Guardant360® CDx liquid biopsy test as a companion diagnostic for VEPPANU (vepdegestrant). VEPPANU, jointly developed by Arvinas, Inc. and Pfizer Inc., is approved for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (
About this update from Guardant Health, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":1128,"height":231,"url":"https://media.zenfs.com/en/business-wire.com/1c88446e9f02ef929a251e404ae8ddd5"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/xAKkssZKL6XBmQw9f3ALFw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTE5Nw--/https://media.zenfs.com/en/business-wire.com/1c88446e9f02ef929a251e404ae8ddd5","width":960,"height":197},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/mQPyWhg.Cf3QiyFmetwXCg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIyNTY7aD00NjI-/https://media.zenfs.com/en/business-wire.com/1c88446e9f02ef929a251e404ae8ddd5","width":1128,"height":231}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"Blood-based test enables identification of patients eligible for targeted treatment with VEPPANU™","length":97,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Approval marks Guardant’s third ESR1 companion diagnostic FDA approval to help guide timely treatment decisions for patients with advanced breast cancer","length":152,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":249,"olType":false},{"type":"text","content":"PALO ALTO, Calif., May 04, 2026--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Guardant360® CDx liquid biopsy test as a companion diagnostic for VEPPANU (vepdegestrant). VEPPANU, jointly developed by Arvinas, Inc. and Pfizer Inc., is approved for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.","length":682,"tagName":"p"},{"type":"text","content":"The approval of Guardant360 CDx enables a non-invasive, blood-based method to identify patients with ESR1 mutations who may be eligible for treatment with VEPPANU. ESR1 mutations are a known mechanism of resistance to endocrine therapy and are commonly observed in patients with advanced disease.","length":296,"tagName":"p"},{"type":"text","content":""This latest FDA approval using Guardant360 CDx reflects...