The FDA approved gedatolisib (Revtorpyk) with fulvestrant, with or without palbociclib, for adults with hormone receptor–positive, HER2-negative advanced breast cancer after progression on endocrine therapy in the metastatic setting when the tumor lacks PIK3CA mutations. The decision was supported by the VIKTORIA-1 phase 3 trial (NCT05501886), where the PIK3CA wild-type cohort saw median progression-free survival of 9.3 months with the triplet (n=131) versus 2.0 months with fulvestrant alone (n=131), and 7.4 months with the doublet. The FDA submission was filed under the Real-Time Oncology Review program. The triplet’s reported any-grade adverse events included stomatitis (69.2%), neutropenia (65.4%), and nausea (43.8%), while overall survival data remained immature and did not reach statistical significance at the May 30, 2025 cutoff.