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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inhibitor pill given accelerated approval in the United States in 2021 for bile duct cancer with an FGFR2 fusion, then withdrawn in 2024 when its confirmatory trial could not enrol; it is now being developed for achondroplasia instead.
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.
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Treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangement as detected by an FDA approved test
Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source
Treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangement as detected by an FDA approved test
Withdrawn: the indication came off the label 3.0 years after its accelerated approval. source
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Previously treated unresectable or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement (accelerated approval) · Indication withdrawn in 2024 |
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Query 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.
Shares Small-molecule kinase inhibitors and the tag chembl-universe.
Shares Small-molecule kinase inhibitors and the tag chembl-universe.
Shares Small-molecule kinase inhibitors and the tag chembl-universe.
Shares FGFR2 fusion or rearrangement, Futibatinib, Pemigatinib, FGFR2.
Shares Futibatinib, FGFR2, Biliary tract cancer (cholangiocarcinoma), Small-molecule kinase inhibitors.
Shares Pemigatinib, FGFR2, Biliary tract cancer (cholangiocarcinoma), Small-molecule kinase inhibitors.
Shares Pemigatinib, Biliary tract cancer (cholangiocarcinoma), Small-molecule kinase inhibitors.
Shares FGFR2, Biliary tract cancer (cholangiocarcinoma), Small-molecule kinase inhibitors.