News
Health Canada approves Truseltiq for cholangiocarcinoma under Project Orbis.
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.
Under Project Orbis, an initiative of the FDA, Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies, Truseltiq received accelerated approval from the FDA in May 2021. An additional marketing application for infigratinib is currently under review in Australia.
Condition: Cholangiocarcinoma
Type: drug
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