乐动体育announced its subsidiary, QED Therapeutics, 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.
乐动体育The company also announced that enrollment is ongoing and patient dosing has started in the , a Phase 3 clinical trial evaluating oral infigratinib in adults for first-line treatment of advanced cholangiocarcinoma with FGFR2 (fibroblast growth factor receptor 2) gene fusions or translocations. The PROOF trial will enroll approximately 384 patients who will be randomized 2:1 to infigratinib versus standard of care. The primary endpoint is progression-free survival compared to standard of care chemotherapy (gemcitabine and cisplatin).
About Infigratinib (BGJ398)
乐动体育Infigratinib (BGJ398) is an orally administered FGFR1-3 tyrosine kinase inhibitor in development for the treatment of patients with FGFR-driven diseases, including cholangiocarcinoma (bile duct cancer. Because infigratinib sparingly inhibits FGFR4, patients may tolerate it better than pan–FGFR1-4 inhibitors. Infigratinib is not chemotherapy.
About Cholangiocarcinoma (bile duct cancer)
Cholangiocarcinoma affects approximately 8,000 to 10,000 individuals a year in the United States. FGFR genetic aberrations are present in about 20% of these cases. These types of aberrations include FGFR2 fusions (or translocations) in which 2 chromosomes exchange parts at the FGFR2 location resulting in a structural rearrangement.Source: