www.fdanews.com/articles/181381-fda-grants-orphan-drug-designation-for-nantcells-ganitumab-in-ewing-sarcoma
FDA Grants Orphan Drug Designation for Nantcell’s Ganitumab in Ewing Sarcoma
April 14, 2017
FDA granted an orphan drug designation to Nantcell’s ganitumab, an insulin growth factor-1r monoclonal antibody therapy for the treatment of patients with Ewing sarcoma.
Ganitumab is a human monoclonal antibody being investigated in a Phase III human clinical trial. It inhibits cancer cell proliferation through disruption of the P13K/Akt and MAPK pathways.
The drug is being developed as a first-line therapy for individuals with newly diagnosed metastatic Ewing sarcoma.