Celcuity Inc discovered Gedatolisib new therapy for the treatment of HR+/HER2- Metastatic Breast Cancer.
Gedatolisib, the first-in-class pan-PI3K/mTOR inhibitor, is applicable for patients progressed with CDK4/6 therapy and a non-steroidal aromatase inhibitor.
Gedatolisib is a potent, reversible dual inhibitor selectively targeting all Class I PI3K isoforms and mTOR. Moreover, mechanism action of Gedatolisib and pharmacokinetic properties can be highly varied from currently available otherinvestigational therapies that target PI3K or mTOR alone or together.
Class 1 PI3K isoforms and mTOR limits the potential growth of drug resistance when compared to that of isoform specific PI3K or mTOR specific inhibitors.
In Phase 1b clinical trial, gedatolisib evaluated manageable side effects in combination with palbociclib and endocrine therapy in patients with HR+/HER2- advanced breast cancer.In addition, phase 3 trial evaluating gedatolisib in patients with HR+/HER2- advanced breast cancer in 2022.
U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy designation for Gedatolisib for Treatment of HR+/HER2- Metastatic Breast Cancer.