The FDA approved Arvinas’ PROTAC breast cancer therapy Veppanu (formerly vepdegestrant) for ESR1-mutated, metastatic estrogen receptor-positive, HER2-negative breast cancer after at least one endocrine therapy, supported by the VERITAC-2 trial. The decision also ties to Guardant Health’s CDx approach for identifying ESR1 mutations. While the approval expands treatment options in a setting with limited effective second-line choices, the FDA action follows a data profile that has left some investors focused on uptake and competitive positioning. Arvinas and Pfizer developed the program, and the label is restricted to the biomarker-defined subgroup. Separately, the FDA also approved Pfizer and Arvinas’ breast cancer drug Veppanu in another report framing the same decision and the role of Guardant Health’s testing pathway.