Pfizer Receives FDA Approval for Vepdegestrant in ESR1-Mutated Breast Cancer

Pfizer today announced that the FDA has approved vepdegestrant for the treatment of adults with ESR1-mutated ER-positive, HER2-negative locally advanced or metastatic breast cancer who have received prior endocrine therapy and a CDK4/6 inhibitor. In the Phase 3 VERITAC-2 trial, vepdegestrant demonstrated a statistically significant improvement in progression-free survival versus fulvestrant. Vepdegestrant is a PROTAC (proteolysis-targeting chimera) that degrades the estrogen receptor, offering a novel mechanism of action. This approval establishes vepdegestrant as a new standard of care in ESR1-mutated breast cancer.