The FDA approved gedatolisib (Revtorpyk) combined with fulvestrant, with or without palbociclib, for adult patients with hormone receptor–positive, HER2-negative advanced breast cancer without a PIK3CA mutation after progression on endocrine therapy in the metastatic setting. The decision was supported by results from the Phase 3 VIKTORIA-1 trial (NCT05501886), including a PIK3CA wild-type cohort. In the VIKTORIA-1 PIK3CA wild-type analysis, gedatolisib plus fulvestrant with palbociclib achieved a median progression-free survival of 9.3 months versus 2.0 months with fulvestrant alone. The doublet regimen also improved PFS to 7.4 months, while overall response rates were reported across arms with stomatitis, neutropenia, and nausea among the more frequent adverse events. The FDA submission was handled under Real-Time Oncology Review, reflecting the agency’s active engagement with an oncology profile that targets a key signaling axis for tumors lacking the common PIK3CA alteration. Overall survival data remained immature at the specified cutoff.