for ESR1-mutated ER+/HER2− advanced or metastatic breast cancer after prior endocrine therapy
NDA· Standard Review
FDA approved Veppanu (vepdegestrant) — the first PROTAC heterobifunctional protein degrader — for ESR1-mutated ER+/HER2− advanced breast cancer after prior endocrine therapy. Approval landed ~5 weeks ahead of the assigned PDUFA date. Pivotal data from VERITAC-2 vs. fulvestrant supported the filing.
About
Veppanu treats a form of advanced breast cancer where tumor growth is driven by the estrogen receptor, a common target for therapy. It works by physically tagging the estrogen receptor protein inside a cell and escorting it to the cell's natural disposal system for destruction. This "tag-and-trash" mechanism, which goes beyond just blocking the receptor, may provide a more durable way to stop cancer growth in patients whose disease has progressed on prior treatments.