Posted by Michael Wonder on 06 Jan 2020
BridgeBio Pharma’s QED Therapeutics receives fast track designation for infigratinib in adults with first-line advanced or metastatic cholangiocarcinoma and orphan drug designation for infigratinib for treatment of cholangiocarcinoma
6 January 2020 - The PROOF trial, a Phase 3 trial of infigratinib in first-line cholangiocarcinoma, is currently enrolling.
BridgeBio Pharma subsidiary QED Therapeutics announced today that it has secured both fast track designation in adults with first-line advanced or metastatic cholangiocarcinoma and orphan drug designation for infigratinib for treatment of cholangiocarcinoma.
In addition, the company announced that enrollment is ongoing and patient dosing has started in the PROOF trial, a Phase 3 clinical trial evaluating oral infigratinib, an investigational drug, in adults for first-line treatment of advanced cholangiocarcinoma with FGFR2 (fibroblast growth factor receptor 2) gene fusions or translocations.
