Pharma Focus Asia
Klöckner Pentaplast - Pentapharm® alfoil® films

Breakthrough Gedatolisib Therapy Discovered for the Treatment of Metastatic Breast Cancer

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.

magazine-slider-imageBIOVIA from Molecule to MedicineMFA + MMA 2024CPHI China || PMEC China 2024Asia Healthcare Week 2024Advance DoE WorkshopCPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinRehab Expo 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference3rd World ADC Asia 2024LogiPharma Asia 2024