Posted by Michael Wonder on 17 Jul 2026
FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR positive, HER2 negative locally advanced or metastatic breast cancer
14 July 2026 - Today, the FDA approved gedatolisib (Revtorpyk, Celcuity) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
Efficacy was evaluated in Study 1 of VIKTORIA-1, an open-label, randomized, multi-centre trial that enrolled 392 adults with locally advanced (inoperable) or metastatic HR-positive, HER2-negative breast cancer.
