BridgeBio and Helsinn’s Truseltiq (infigratinib) Receive the US FDA’s Approval for Cholangiocarcinoma

Shots:

• The approval is based on a P-II study assessing Truseltiq (125mg, qd, for 21 days of 28-day cycles) in 108 patients who had undergone at least one prior treatment for advanced CCA. Out of 108, 107 had Stage IV CCA
• Results: ORR (23%); mDOR (5mos.); presented at ASCO 2021. Additional marketing applications for Truseltiq are currently under review in Australia and Canada under Project Orbis
• Truseltiq is an ATP-competitive, TKI of FGFR. BridgeBio, through its affiliate QED & Helsinn will co-commercialize Truseltiq in the US under its collaboration signed in Mar’2021

Click here to­ read full press release/ article | Ref: Bridge Bio | Image: PR Newswire