The committee felt the drug failed to show a favorable risk-benefit ratio and questioned the equipose of the trial design, which allowed control arm patients who used sorafenib to transition to tivozanib following progression disease but not those on the experimental arm using tivozanib to transition to sorafenib. The application was formally rejected by the FDA in June 2013, saying that approval would require additional clinical studies.In 2016, AVEO Oncology published data in conjunction with the ASCO meeting showing a geographical location effect on overall survival in the Phase III trial.In 2016, AVEO Oncology announced the start of a second Phase III clinical study in third line advanced RCC patients.In 2016, EUSA Pharma and AVEO Oncology announced that tivozanib had been submitted to the European Medicines Agency for review under the centralised procedure.In June 2017, the EMA Scientific Committee recommended tivozanib for approval in Europe, with approval expected in September.In August 2017, the European Commission (EC) formally approved tivozanib in Europe. References
External links
"Tivozanib". Drug Information Portal. U.S. National Library of Medicine.
Infigratinib, sold under the brand name Truseltiq, is an anti-cancer medication used to treat cholangiocarcinoma (bile duct cancer).Infigratinib is a kinase inhibitor targeting the fibroblast growth factor receptors FGFR1, FGFR2 and FGFR3 It was designated an orphan drug by the U.S. Food and Drug Administration (FDA) in 2019, and it was approved for medical use in the United States in May 2021. Medical uses
Infigratinib is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. References
External links
"Infigratinib". Drug Information Portal. U.S. National Library of Medicine. Clinical trial number NCT02150967 for "A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma" at ClinicalTrials.gov