for ESR1-mutated ER+/HER2− advanced or metastatic breast cancer after prior endocrine therapy
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.
Estrogen receptor-positive (ER+) breast cancer grows when estrogen activates the ER protein, and ESR1 mutations make tumors resistant to standard hormone therapies. Veppanu is a PROTAC drug that tags the faulty ER protein for destruction by the cell's waste disposal system, unlike traditional blockers that just occupy the receptor. By eliminating the mutated ER entirely, Veppanu may overcome resistance in advanced cases where other treatments fail.
The purpose of this study is to understand the safety and effects of the study medicine vepdegestrant (ARV-471/PF-07850327) given together with palbociclib in advanced breast cancer. In particular, the study will compare the combination of vepdegestrant plus palbociclib to standard of care therapy (letrozole plus palbociclib)
Source: ClinicalTrials.gov