Posted by Michael Wonder on 20 Jan 2022
Celcuity receives FDA fast track designation for gedatolisib in HR positive, HER2 negative metastatic breast cancer
18 January 2022 - On track to finalise Phase 3 clinical trial design for gedatolisib with FDA feedback in first quarter.
Celcuity today announced that the U.S. FDA has granted fast track designation to the Company's lead drug candidate, gedatolisib, for the treatment of patients with hormone receptor positive, HER2 negative metastatic breast cancer after progression on CDK4/6 therapy.
