QED Therapeutics’ Infigratinib Gets Orphan Drug and Fast Track Designations

The FDA handed QED Therapeutics’ both orphan drug and fast track designations for its investigational treatment infigratinib.

The drug received a fast track designation for first-line treatment of adult patients with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or translocations. The drug also earned an orphan drug designation for the treatment of bile duct cancer.

Infigratinib is an orally administered FGFR1-3 tyrosine kinase inhibitor for treatment of patients with FGFR-driven diseases, including bile duct cancer, bladder cancer and achondroplasia dwarfism.