FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer

In July 2026, the U.S. Food and Drug Administration approved gedatolisib plus fulvestrant, with or without palbociclib, for adults with HR+ HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.