Infigratinib

Pregnancy
categoryRoutes of
administrationBy mouthDrug classTyrosine kinase inhibitorATC codeLegal statusLegal status IdentifiersCAS NumberPubChem CIDDrugBankChemSpiderUNIIKEGGCompTox Dashboard (EPA)Chemical and physical dataFormulaC₂₆H₃₁Cl₂N₇O₃Molar mass560.48 g·mol⁻¹3D model (JSmol)

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]}

Medical uses

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]

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 ).^[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]

History

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]

Society and culture

Legal status

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]

References

External links

• Clinical trial number NCT02150967 for "A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma" at ClinicalTrials.gov