Pfizer, Arvinas FDA Approve Veppanu Breast Cancer Pill

FDA grants approval to Pfizer and Arvinas' oral breast cancer drug Veppanu for advanced ER‑positive, HER2‑negative tumors.
Late‑stage trial of 624 patients showed longer progression‑free survival and higher tumor‑shrinkage versus fulvestrant.
FDA also cleared Guardant360 CDx test for ESR1 mutation and recommends daily 200 mg pill with food, noting cardiac and fetal risks.
Arvinas plans commercialization agreement soon; analysts view tolerability as compelling but note differentiation challenges across trials.