What did the FDA approval of gedatolisib and fulvestrant mean for HR-positive HER2-negative breast cancer?

In July 2026, the FDA approved gedatolisib (Revtorpyk, Celcuity) with fulvestrant, with or without palbociclib, for HR‑positive, HER2‑negative breast cancer lacking PIK3CA mutations after endocrine therapy. The VIKTORIA‑1 trial showed improved progression‑free survival over fulvestrant alone, marking a new targeted option in this hard‑to‑treat population.