The FDA approved gedatolisib (Revtorpyk) plus fulvestrant, with or without palbociclib, for hormone receptor–positive, HER2-negative advanced breast cancer without a PIK3CA mutation after progression on endocrine therapy. The decision was supported by results from the VIKTORIA-1 phase 3 trial, including the PIK3CA wild-type cohort. In that cohort, adding the triplet improved median progression-free survival to 9.3 months versus 2.0 months with fulvestrant alone, with the doublet arm also outperforming. The regimen produced characteristic toxicities, including stomatitis and neutropenia, while overall survival remained immature at the cutoff. The approval also followed an FDA Real-Time Oncology Review pathway, underscoring regulators’ focus on speed for high-need, biomarker-defined oncology settings.