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Mogamulizumab

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Mogamulizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCCR4
Clinical data
Pronunciationmoe gam" ue liz' ue mab
Trade namesPoteligeo
Other namesmogamulizumab-kpkc
AHFS/Drugs.comMonograph
MedlinePlusa618064
License data
Pregnancy
category
Routes of
administration		Intravenous
Drug classAntineoplastic agent
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6520H10072N1736O2020S42
Molar mass146444.95 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Mogamulizumab, sold under the brand name Poteligeo, is a humanized, afucosylated monoclonal antibody targeting CC chemokine receptor type 4 (CCR4).[5][7] It is given by injection into a vein.[5][6]

The most common side effects include rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection.[8]

Mogamulizumab was approved for medical use in Japan in 2012. It was approved for medical use in the United States and the European Union in 2018.[5][6] It was approved for medical use in Canada in 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9]

Medical uses

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Mogamulizumab is indicated for the treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.[5][6][8]

History

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The precursor to mogamulizumab was a mouse anti-human CCR4 IgG1 mAb (KM2160), that was made in 1996 in a collaboration between Kouji Matsushima of University of Tokyo and Kyowa Hakko Kirin. Kyowa humanized it, and expressed the humanized gene in a CHO cell line in which FUT8 had been knocked out, which produced antibodies with no fucose in the Fc region.[7][10] This is thought to enhance its antibody-dependent cell-mediated cytotoxicity.[11] It was first tested in humans in 2007.[10]

Kyowa licensed rights for use outside of cancer to Amgen in 2008, for $100 million up front and $420 million in biodollars.[12] Amgen ran a Phase I study to explore its use in asthma.[13] Amgen terminated the agreement in 2014.[12]

In 2017, the US FDA granted the application for mogamulizumab a priority review for cutaneous T cell lymphoma.[14] Full approval was granted by the FDA in August 2018.[8] The FDA approval was based on a clinical trial of 372 participants with relapsed mycosis fungoides or Sézary syndrome who received either mogamulizumab or a type of chemotherapy called vorinostat. The FDA granted the application for mogamulizumab priority review, breakthrough therapy, and orphan drug designations. The FDA granted the approval of Poteligeo to Kyowa Kirin, Inc.

Society and culture

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The US Food and Drug Administration (FDA) approved mogamulizumab in August 2018,[15] for the treatment of relapsed or refractory mycosis fungoides and Sézary disease.[8] Mogamulizumab was approved in Japan in 2012, for the treatment of relapsed or refractory CCR4+ adult T-cell leukemia/lymphoma and in 2014, for relapsed or refractory CCR4+ cutaneous T cell lymphoma.[7] The latter approval was based on study with 28 participants.[16]

Mogamulizumab was approved for medical use in the European Union in November 2018,[6] and in Canada in June 2022.

Research

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Mogamulizumab is being explored as a treatment for HTLV-1–Associated Myelopathy. An early Phase 1-2a study showed decreased in proviral loads, as well as inflammatory markers in the CSF. 79% of the patients showed reduction in spasticity and 32% showed decrease in motor disability.[17]

References

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  1. ^ a b "Poteligeo". Therapeutic Goods Administration (TGA). 15 February 2021. Archived from the original on 9 September 2021. Retrieved 8 September 2021.
  2. ^ a b "AusPAR: Mogamulizumab". Therapeutic Goods Administration (TGA). 10 May 2021. Archived from the original on 9 September 2021. Retrieved 8 September 2021.
  3. ^ "Poteligeo Product information". Health Canada. 25 April 2012. Archived from the original on 1 October 2022. Retrieved 30 September 2022.
  4. ^ "Summary Basis of Decision - Poteligeo". Health Canada. 23 October 2014. Archived from the original on 28 November 2022. Retrieved 28 November 2022.
  5. ^ a b c d e "Poteligeo- mogamulizumab-kpkc injection". DailyMed. 27 April 2023. Retrieved 15 May 2024.
  6. ^ a b c d e "Poteligeo EPAR". European Medicines Agency (EMA). 14 October 2016. Archived from the original on 5 July 2021. Retrieved 15 May 2024.
  7. ^ a b c Yu X, Marshall MJ, Cragg MS, Crispin M (June 2017). "Improving Antibody-Based Cancer Therapeutics Through Glycan Engineering" (PDF). BioDrugs. 31 (3): 151–166. doi:10.1007/s40259-017-0223-8. PMID 28466278. S2CID 3722081. Archived (PDF) from the original on 26 August 2021. Retrieved 15 May 2024.
  8. ^ a b c d "FDA approves treatment for two rare types of non-Hodgkin lymphoma". U.S. Food and Drug Administration (FDA) (Press release). 8 August 2018. Archived from the original on 15 July 2021. Retrieved 15 May 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  9. ^ New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Archived from the original on 17 September 2020. Retrieved 16 September 2020.
  10. ^ a b Ueda R (2015). "Clinical Application of Anti-CCR4 Monoclonal Antibody". Oncology. 89 (Suppl 1): 16–21. doi:10.1159/000431059. PMID 26550987. S2CID 24091636.
  11. ^ "Available Agents: Mogamulizumab". NCI Formulary. Archived from the original on 11 May 2018. Retrieved 11 May 2018.
  12. ^ a b Carroll J (25 August 2017). "After a long clinical odyssey, the FDA tapped this PhIII anti-CCR4 as a 'breakthrough' lymphoma drug". Endpoints. Archived from the original on 31 October 2021. Retrieved 11 May 2018.
  13. ^ Pease JE, Horuk R (May 2014). "Recent progress in the development of antagonists to the chemokine receptors CCR3 and CCR4". Expert Opinion on Drug Discovery. 9 (5): 467–83. doi:10.1517/17460441.2014.897324. PMID 24641500. S2CID 32596704.
  14. ^ Adamson L (22 January 2018). "Mogamulizumab Receives Priority Review for CTCL - ASH Clinical News". ASH Clinical News. Archived from the original on 10 May 2018. Retrieved 10 May 2018.
  15. ^ "Drug Approval Package: Poteligeo (mogamulizumab-kpkc)". U.S. Food and Drug Administration (FDA). 7 September 2018. Retrieved 15 May 2024.
  16. ^ Broccoli A, Argnani L, Zinzani PL (November 2017). "Peripheral T-cell lymphomas: Focusing on novel agents in relapsed and refractory disease". Cancer Treatment Reviews. 60: 120–129. doi:10.1016/j.ctrv.2017.09.002. PMID 28946015.
  17. ^ Sato T, Coler-Reilly AL, Yagishita N, Araya N, Inoue E, Furuta R, et al. (February 2018). "Mogamulizumab (Anti-CCR4) in HTLV-1-Associated Myelopathy". The New England Journal of Medicine. 378 (6): 529–538. doi:10.1056/NEJMoa1704827. PMID 29414279.
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