Gilteritinib Explained

Tradename:Xospata
Dailymedid:Gilteritinib
Pregnancy Au:D
Pregnancy Au Comment:[1]
Routes Of Administration:By mouth
Atc Prefix:L01
Atc Suffix:EX13
Legal Au:S4
Legal Ca:Rx-only
Legal Ca Comment:[2]
Legal Uk:POM
Legal Uk Comment:[3]
Legal Us:Rx-only
Legal Us Comment:[4]
Legal Eu:Rx-only
Legal Eu Comment:[5]
Legal Status:Rx-only
Index2 Label:as salt
Cas Number:1254053-43-4
Chemspiderid:32055842
Pubchem:49803313
Chebi:145372
Drugbank:DB12141
Unii:66D92MGC8M
Kegg:D10709
Kegg2:D10800
Iupac Name:6-Ethyl-3-[3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]anilino]-5-(oxan-4-ylamino)pyrazine-2-carboxamide
C:29
H:44
N:8
O:3
Smiles:CCc1nc(C(=O)N)c(Nc2ccc(N3CCC(CC3)N4CCN(C)CC4)c(OC)c2)nc1NC5CCOCC5
Stdinchi:1S/C29H44N8O3/c1-4-23-28(31-20-9-17-40-18-10-20)34-29(26(33-23)27(30)38)32-21-5-6-24(25(19-21)39-3)37-11-7-22(8-12-37)36-15-13-35(2)14-16-36/h5-6,19-20,22H,4,7-18H2,1-3H3,(H2,30,38)(H2,31,32,34)
Stdinchikey:GYQYAJJFPNQOOW-UHFFFAOYSA-N

Gilteritinib, sold under the brand name Xospata, is an anti-cancer drug.[6] It acts as an inhibitor of FLT3, hence it is a tyrosine kinase inhibitor.[7]

It was developed by Astellas Pharma.

In April 2018, Astellas filed a new drug application with the Food and Drug Administration for gilteritinib for the treatment of adult patients with FLT3 mutation–positive (both ITD and TKD[8]) relapsed or refractory acute myeloid leukemia (AML).[9]

In November 2018, the FDA approved gilteritinib for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.[10]

Gilteritinib was granted orphan drug status by the U.S. FDA, the European Commission (EC) and the Japan Ministry of Health, Labor and Welfare, for some AML patients.[11]

Gilteritinib was approved for medical use in Australia in March 2020.[12]

Further reading

External links

Notes and References

  1. Web site: Xospata Australian prescription medicine decision summary . Therapeutic Goods Administration (TGA) . 11 April 2020 . 16 August 2020.
  2. Web site: Summary Basis of Decision (SBD) for Xospata . . 23 October 2014 . 29 May 2022.
  3. Web site: Xospata 40 mg film-coated tablets - Summary of Product Characteristics (SmPC) . (emc) . 13 November 2019 . 16 August 2020.
  4. Web site: Xospata- gilteritinib tablet . DailyMed . 31 May 2019 . 16 August 2020.
  5. Web site: Xospata EPAR . European Medicines Agency (EMA) . 16 September 2019 . 16 August 2020.
  6. Perl AE, Altman JK, Cortes J, Smith C, Litzow M, Baer MR, Claxton D, Erba HP, Gill S, Goldberg S, Jurcic JG, Larson RA, Liu C, Ritchie E, Schiller G, Spira AI, Strickland SA, Tibes R, Ustun C, Wang ES, Stuart R, Röllig C, Neubauer A, Martinelli G, Bahceci E, Levis M . Selective inhibition of FLT3 by gilteritinib in relapsed or refractory acute myeloid leukaemia: a multicentre, first-in-human, open-label, phase 1-2 study . The Lancet. Oncology . 18 . 8 . 1061–1075 . August 2017 . 28645776 . 5572576 . 10.1016/S1470-2045(17)30416-3 .
  7. Lee LY, Hernandez D, Rajkhowa T, Smith SC, Raman JR, Nguyen B, Small D, Levis M . Preclinical studies of gilteritinib, a next-generation FLT3 inhibitor . Blood . 129 . 2 . 257–260 . January 2017 . 27908881 . 5234222 . 10.1182/blood-2016-10-745133 .
  8. Molica M, Perrone S, Rossi M . Gilteritinib: The Story of a Proceeding Success into Hard-to-Treat FLT3-Mutated AML Patients . Journal of Clinical Medicine . 12 . 11 . 3647 . May 2023 . 37297842 . 10253262 . 10.3390/jcm12113647 . free .
  9. News: FDA Approval Sought for Gilteritinib in FLT3+ AML . onclive.com . April 24, 2018 . September 29, 2018.
  10. Web site: FDA approves gilteritinib for relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation . U.S. Food and Drug Administration (FDA) . 2018-11-28 . 2018-11-29.
  11. Web site: U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) . Drugs.com . 2018-12-03.
  12. Web site: AusPAR: Gilteritinib (as fumarate) . Therapeutic Goods Administration (TGA) . 11 September 2020 . 23 September 2020.

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