The FDA approved gedatolisib (Revtorpyk) plus fulvestrant, with or without palbociclib, for adults with hormone receptor-positive, HER2-negative advanced breast cancer without a PIK3CA mutation following progression on endocrine therapy. The decision was supported by VIKTORIA-1 data in the PIK3CA wild-type cohort, where the gedatolisib regimens significantly improved progression-free survival versus fulvestrant alone.