The FDA approved gedatolisib (Revtorpyk) plus fulvestrant, with or without palbociclib, for PIK3CA wild-type hormone receptor–positive, HER2-negative advanced breast cancer after progression on endocrine therapy. The decision followed results from the VIKTORIA-1 phase 3 trial. In the PIK3CA wild-type cohort, the triplet regimen achieved median progression-free survival (PFS) of 9.3 months versus 2.0 months with fulvestrant alone, with an adjusted hazard ratio of 0.24 (P<.0001). The doublet arm also improved PFS to 7.4 months (HR 0.33; P<.0001), while overall response rates were highest in the triplet arm. Adverse events in the triplet arm included stomatitis, neutropenia, and nausea, and overall survival remained immature at the May 30, 2025 cutoff. The FDA reviewed the new drug application under Real-Time Oncology Review.