First-in-Class Vepdegestrant Approved in Advanced Breast Cancer

— Oral agent in second-line more than doubled median PFS in patients with ESR1 mutations May 1, 2026 • 2 min read The FDA approved oral vepdegestrant (Veppanu) for adults with advanced or metastatic estrogen receptor (ER)-positive/HER2-negative breast cancer, the agency announced on Friday. Approval of the first-in-class proteolysis targeting chimera (PROTAC) -- a type of heterobifunctional protein degrader therapy -- stipulates use in patients with ESR1-mutated disease that has progressed following at least one line of endocrine therapy. Findings of the global phase III VERITAC-2 trial showed that among patients with ESR1-mutated disease, vepdegestrant reduced the risk of disease progression or death by 43% compared with fulvestrant (Faslodex), with a median progression-free survival (PFS) of 5 months versus 2.1 months, respectively (HR 0.57, 95% CI 0.42-0.77, P=0.0001). "For patients living with ESR1 mutant, [ER-positive/HER2-negative] advanced breast cancer, there have been minimal second-line treatment options once standard therapies are no longer effective," investigator Erika Hamilton, MD, of the Sarah Cannon Research Institute in Nashville, Tennessee, said in a press release from drugmaker Arvinas. "The introduction of a new, targeted treatment is an encouraging development for this community and highlights meaningful innovation in the way this disease is treated," Hamilton added.