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
Breast cancer driven by estrogen receptors can progress after initial hormone therapies, especially when the receptor itself acquires specific mutations. Vepdegestrant is a protein degrader that enters cells and tags the estrogen receptor for disposal by the cell's own waste-removal system. By eliminating the mutated receptor that fuels the cancer's growth, this drug may provide a new treatment path when prior therapies stop working.