FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Grants Orphan Drug Designation for Nantcell’s Ganitumab in Ewing Sarcoma

April 17, 2017
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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.

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