Health Canada conditional approval of Truseltiq for cholangiocarcinoma

On the heels of a US Food and Drug Administration approval earlier this year, privately-held Swiss firm Helsinn Group and USA-based BridgeBio Pharma (Nasdaq: BBIO), through its affiliate QED Therapeutics, today announced that Health Canada has conditionally approved Truseltiq (infigratinib).

This small molecule kinase inhibitor that targets fibroblast growth factor receptor (FGFR) has been cleared under 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.

“This is an important next step in growing Truseltiq’s global reach. We are pleased to have achieved this milestone for patients with previously-treated locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or other rearrangement,” said Riccardo Braglia, Helsinn’s group vice chairman and chief executive.