FDA approves Pemazyre to treat cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion.- Incyte Corpn.
Related news and insights
Helsinn Group a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, announced that the European Medicines Agency (EMA) accepted for review the Company’s Marketing Authorization Application (MAA) for infigratinib for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
Helsinn Group and BridgeBio Pharma announced that Health Canada has approved Truseltiq (infigratinib), a small molecule kinase inhibitor that targets fibroblast growth factor receptor (FGFR), under Project Orbis, the Notice of Compliance with Conditions (NOC/c) policy, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or other rearrangement.
Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Merck KGaA has decided to discontinue the Phase II INTR@PID BTC 055 study evaluating bintrafusp alfa with gemcitabine plus cisplatin in the first-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC), as the study is unlikely to achieve the primary objective of overall survival. No new safety signals were identified.