Clinical data | |
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Trade names | Truseltiq |
Other names | BGJ-398 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a621041 |
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Pregnancy category | |
Routes of administration | By mouth |
Drug class | Tyrosine kinase inhibitor |
ATC code | |
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Chemical and physical data | |
Formula | C26H31Cl2N7O3 |
Molar mass | 560.48 g·mol−1 |
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Infigratinib, sold under the brand name Truseltiq, is an anti-cancer medication used to treat cholangiocarcinoma (bile duct cancer).[1][4]
The most common side effects include increased phosphate level in the blood, increased creatinine levels in the blood, nail changes, mouth sores, dry eye, fatigue, alopecia, and palmar-plantar erythrodysesthesia (rash, redness, pain, swelling or blisters on the palms of the hands or soles of the feet).[5][6]
Infigratinib is a kinase inhibitor targeting the fibroblast growth factor receptors FGFR1, FGFR2, and FGFR3.[4][7]
Infigratinib was approved for medical use in the United States in May 2021.[4][5][6][8][9]
Infigratinib is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.[4][5]
The most common side effects include increased phosphate level in the blood, increased creatinine levels in the blood, nail changes, mouth sores, dry eye, fatigue, alopecia, and palmar-plantar erythrodysesthesia (rash, redness, pain, swelling or blisters on the palms of the hands or soles of the feet ).[5]
Infigratinib may cause serious side effects including detachment of retina (inner layer of the eye), increased phosphate level in the blood, and harm to an unborn baby.[5]
The US Food and Drug Administration (FDA) approved infigratinib based on evidence from one clinical trial (NCT02150967) of 108 participants with bile duct cancer (cholangiocarcinoma).[5] The CBGJ398X2204 trial was a multicenter open-label single-arm trial that enrolled 108 participants with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement as determined by local or central testing.[6] The trials were conducted at 18 sites in the United States, Europe, and Asia.[5] The trial enrolled adult participants with bile duct cancer who had been treated previously with chemotherapy for their advanced cancer and whose tumors had a certain type of abnormality in the FGFR2 gene.[5] Participants received infigratinib once daily by mouth for 21 consecutive days followed by 7 days off therapy.[5] This 28-day cycle was administered until disease progression or the side effects became too toxic.[5] The trial measured the percentage of participants who achieved partial or complete shrinkage of their cancer and how long that shrinkage lasted (duration of response or DoR).[5]
The FDA granted the application for infigratinib priority review, fast track, and orphan drug designations.[6]
Infigratinib was designated an orphan drug by the FDA[10] and the European Medicines Agency in 2021.[11] It was approved for medical use under the FDA's accelerated approval program in May 2021.[5][6]