Infigratinib is not currently FDA approved for this indication in the U.S. and is not approved for use by any other health authority.
QED has partnered with the Cholangiocarcinoma Foundation, whose mission is to find a cure and improve the quality of life for those affected by cholangiocarcinoma (bile duct cancer). This partnership allows QED to collaborate with leading disease experts in the Cholangiocarcinoma Foundation network.
Urothelial Carcinoma (Urinary Tract and Bladder Cancer)
FGFR3 genetic alterations are an oncogenic driver in some urothelial carcinomas. FGFR3 genetic alterations are found in:
21% of advanced urothelial bladder carcinomas10,11
Up to 74% of all stages of upper tract urothelial carcinomas (UTUCs)12
Estimates suggest that 21%-38% of invasive (≥T2) UTUC harbor FGFR3 genetic alterations11-15
FGFR=fibroblast growth factor receptor.
PROOF 302 is a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial of infigratinib* for the adjuvant treatment of subjects with invasive urothelial carcinoma with FGFR3 genetic alterations. This trial is currently open and enrolling.