FDA Approves New Breast Cancer Drug Gedatolisib Based on Positive VIKTORIA-1 Study Results

The U.S. Food and Drug Administration (FDA) has approved gedatolisib, a kinase inhibitor, for the treatment of ER+/HER2- locally advanced or metastatic breast cancer. The approval is based on results from the Study 1 VIKTORIA-1 trial, which demonstrated that gedatolisib significantly improved time without cancer progression and limited treatment side effects by blocking a signaling pathway often used to drive tumor growth and treatment resistance.