— Gedatolisib is approved in combination with fulvestrant, with or without palbociclib
July 14, 2026
• 2 min read
The FDA approved the kinase inhibitor gedatolisib (Revtorpyk) for treating hormone receptor (HR)-positive/HER2-negative breast cancer in patients whose disease has progressed on endocrine therapy in the metastatic setting.
Approval of the PI3K/AKT/mTOR (PAM) inhibitor stipulates use in combination with fulvestrant -- with or without the CDK4/6 inhibitor palbociclib (Ibrance) -- in adults without PIK3CA mutations.
