Summary
Infigratinib, sold under the brand name Truseltiq, is an anti-cancer medication used to treat cholangiocarcinoma (bile duct cancer).[1][4]
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| Trade names | Truseltiq |
| Other names | BGJ-398 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a621041 |
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| Routes of administration | By mouth |
| Drug class | Tyrosine kinase inhibitor |
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| Formula | C26H31Cl2N7O3 |
| Molar mass | 560.48 g·mol−1 |
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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 edit
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 edit
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 edit
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 edit
Legal status edit
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 edit
- ^ a b c "Truseltiq". Therapeutic Goods Administration (TGA). 22 November 2021. Retrieved 28 December 2021.
- ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Archived from the original on 3 April 2022. Retrieved 13 May 2022.
- ^ "Summary Basis of Decision (SBD) for Truseltiq". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
- ^ a b c d e "Truseltiq- infigratinib capsule". DailyMed. Archived from the original on 10 June 2021. Retrieved 10 June 2021.
- ^ a b c d e f g h i j k l "Drug Trials Snapshots: Truseltiq". U.S. Food and Drug Administration (FDA). 28 May 2021. Archived from the original on 28 July 2023. Retrieved 1 August 2023.
This article incorporates text from this source, which is in the public domain.
- ^ a b c d e "FDA grants accelerated approval to infigratinib for metastatic cholang". U.S. Food and Drug Administration. 28 May 2021. Archived from the original on 2 August 2023. Retrieved 1 August 2023. This article incorporates text from this source, which is in the public domain.
- ^ Botrus G, Raman P, Oliver T, Bekaii-Saab T (April 2021). "Infigratinib (BGJ398): an investigational agent for the treatment of FGFR-altered intrahepatic cholangiocarcinoma". Expert Opinion on Investigational Drugs. 30 (4): 309–316. doi:10.1080/13543784.2021.1864320. PMID 33307867. S2CID 229177726.
- ^ "BridgeBio Pharma's Affiliate QED Therapeutics and Partner Helsinn Group Announce FDA Approval of Truseltiq (infigratinib) for Patients with Cholangiocarcinoma" (Press release). BridgeBio Pharma. 28 May 2021. Retrieved 28 May 2021 – via GlobeNewswire.
- ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.
- ^ "Infigratinib Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 11 September 2019. Archived from the original on 28 October 2022. Retrieved 30 May 2021.
- ^ "EU/3/21/2475". European Medicines Agency. 13 June 2022. Archived from the original on 30 May 2023. Retrieved 1 August 2023.
External links edit
- Clinical trial number NCT02150967 for "A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma" at ClinicalTrials.gov
