Infigratinib, sold under the brand name Truseltiq, is an anti-cancer medication used to treat

cholangiocarcinoma Cholangiocarcinoma, also known as bile duct cancer, is a type of cancer that forms in the bile ducts. Symptoms of cholangiocarcinoma may include abdominal pain, yellowish skin, weight loss, generalized itching, and fever. Light colored stool ...

(

bile duct A bile duct is any of a number of long tube-like structures that carry bile, and is present in most vertebrates. Bile is required for the digestion of food and is secreted by the liver into passages that carry bile toward the hepatic duct. It ...

cancer). 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). Infigratinib is a

kinase inhibitor A protein kinase inhibitor is a type of enzyme inhibitor that blocks the action of one or more protein kinases. Protein kinases are enzymes that phosphorylate (add a phosphate, or PO4, group) to a protein and can modulate its function. The phospha ...

targeting the fibroblast growth factor receptors FGFR1, FGFR2, and FGFR3. Infigratinib was approved for medical use in the United States in May 2021.

Medical uses

Infigratinib is indicated for the treatment of adults with previously treated, un resectable locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with a

fibroblast growth factor receptor 2 Fibroblast growth factor receptor 2 (FGFR2) also known as CD332 (cluster of differentiation 332) is a protein that in humans is encoded by the ''FGFR2'' gene residing on chromosome 10. FGFR2 is a receptor for fibroblast growth factor. The protein ...

(FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

Adverse effects

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 ). 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.

History

The US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) approved infigratinib based on evidence from one clinical trial (NCT02150967) of 108 participants with bile duct cancer (cholangiocarcinoma). 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. The trials were conducted at 18 sites in the United States, Europe, and Asia. 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. Participants received infigratinib once daily by mouth for 21 consecutive days followed by 7 days off therapy. This 28-day cycle was administered until disease progression or the side effects became too toxic. 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). The FDA granted the application for infigratinib priority review, fast track, and

orphan drug An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of ...

designations.

Society and culture

Legal status

Infigratinib was designated an

by the FDA and the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...

in 2021. It was approved for medical use under the FDA's accelerated approval program in May 2021.

References

External links

* {{Portal bar , Medicine Orphan drugs Receptor tyrosine kinase inhibitors