What specific patient population is Veppanu approved for, and what genetic biomarker must they have?

Veppanu is approved for adults with estrogen receptor-positive, HER2-negative breast cancer that has metastasized or is unresectable, who carry an ESR1 mutation and have experienced disease progression after at least one prior hormone therapy.

What evidence supported the FDA's approval of Veppanu, and how did it compare to existing treatment?

The FDA's approval was based on a late-stage trial of 624 participants showing Veppanu helped patients survive longer without breast cancer worsening compared to fulvestrant, an older hormone therapy; the drug also demonstrated greater tumor shrinkage than injectable drugs, and had a compelling tolerability profile according to Wedbush analyst Robert Driscoll.

US FDA Approves Pfizer, Arvinas Breast Cancer Drug

May 1, 2026

The US FDA approved Pfizer and Arvinas' breast cancer drug Veppanu for patients with ESR1-mutated advanced disease. Clinical trials demonstrated improved survival over standard therapy, accompanied by the approval of a companion diagnostic test.

reuters

2026-05-01

US FDA Approves Pfizer, Arvinas Breast Cancer Drug

US FDA Approves Pfizer, Arvinas Breast Cancer Drug

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