Infigratinib
Infigratinib is an FGFR inhibitor pill given accelerated approval in the United States in 2021 for bile duct cancer with an FGFR2 fusion, then withdrawn in 2024 when its confirmatory trial could not enrol; it is now being developed for achondroplasia instead.
Overview
Infigratinib, discovered at Novartis and developed by BridgeBio's QED Therapeutics with Helsinn, received FDA accelerated approval in May 2021 for previously treated, unresectable or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement, on a response rate of about 23 percent in a single-arm phase 2 trial. The first-line confirmatory trial PROOF 301 struggled to recruit against pemigatinib and futibatinib, and the sponsors withdrew the cholangiocarcinoma indication in 2024. Hyperphosphataemia, eye and nail changes are the FGFR class effects. BridgeBio continues the molecule at low dose for children with achondroplasia.
An ATP-competitive inhibitor of FGFR1, FGFR2 and FGFR3 kinases; tumours driven by FGFR2 fusions depend on that signalling and shrink when it is blocked. Connects to FGFR2.
1.Infigratinib slips into a pocket on FGFR2.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Previously treated unresectable or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement (accelerated approval) · Indication withdrawn in 2024 |
Trials
topTrials recruiting now
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Latest papers
topQuery for this drug: (TITLE:"Infigratinib" OR ABSTRACT:"Infigratinib" OR TITLE:"Truseltiq" OR ABSTRACT:"Truseltiq" OR TITLE:"BGJ398" OR ABSTRACT:"BGJ398") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Infigratinib, not a curated reading list.
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