Posted by Michael Wonder on 18 Jul 2022
Celcuity announces FDA breakthrough therapy designation for gedatolisib for treatment of HR positive, HER2 negative metastatic breast cancer
18 July 2022 - Celcuity today announced that the U.S. FDA has granted gedatolisib breakthrough therapy designation for the treatment of patients with HR positive, HER2 negative metastatic breast cancer whose disease progressed during treatment with a CDK4/6 therapy and a non-steroidal aromatase inhibitor.
Gedatolisib is a potential first in class pan-PI3K/mTOR inhibitor.
