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
Ref: Bridge Bio | Image: PR Newswire
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