Infigratinib

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Infigratinib
Clinical data
Trade namesTruseltiq
Other namesBGJ-398
AHFS/Drugs.comMonograph
MedlinePlusa621041
License data
Pregnancy
category
Routes of
administration		By mouth
Drug classTyrosine kinase inhibitor
ATC code
Legal status
Legal status
Identifiers
JSmol)
  • CCN1CCN(c2ccc(Nc3cc(N(C)C(=O)Nc4c(Cl)c(OC)cc(OC)c4Cl)ncn3)cc2)CC1
  • InChI=1S/C26H31Cl2N7O3/c1-5-34-10-12-35(13-11-34)18-8-6-17(7-9-18)31-21-15-22(30-16-29-21)33(2)26(36)32-25-23(27)19(37-3)14-20(38-4)24(25)28/h6-9,14-16H,5,10-13H2,1-4H3,(H,32,36)(H,29,30,31)
  • Key:QADPYRIHXKWUSV-UHFFFAOYSA-N

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

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, un

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

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

  1. ^ a b c "Truseltiq". Therapeutic Goods Administration (TGA). 22 November 2021. Retrieved 28 December 2021.
  2. ^ "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.
  3. ^ "Summary Basis of Decision (SBD) for Truseltiq". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  4. ^ a b c d e "Truseltiq- infigratinib capsule". DailyMed. Archived from the original on 10 June 2021. Retrieved 10 June 2021.
  5. ^ 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. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ^ 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. Public Domain This article incorporates text from this source, which is in the public domain.
  7. S2CID 229177726
    .
  8. ^ "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.
  9. ^ 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. Public Domain This article incorporates text from this source, which is in the public domain.
  10. ^ "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.
  11. ^ "EU/3/21/2475". European Medicines Agency. 13 June 2022. Archived from the original on 30 May 2023. Retrieved 1 August 2023.

External links

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