Mogamulizumab

Source: Wikipedia, the free encyclopedia.

Mogamulizumab
Humanized (from mouse)
TargetCCR4
Clinical data
Pronunciationmoe gam" ue liz' ue mab
Trade namesPoteligeo
Other namesmogamulizumab-kpkc
AHFS/Drugs.comMonograph
MedlinePlusa618064
License data
Pregnancy
category
Intravenous
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,

cutaneous T cell lymphoma (CTCL).[5] The latter approval was based on study with 28 subjects.[7]

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

antibody-dependent cell-mediated cytotoxicity.[9] It was first tested in humans in 2007.[8]

Kyowa licensed rights for use outside of cancer to Amgen in 2008, for $100 million up front and $420 million in biodollars.[10] Amgen ran a Phase I study to explore its use in asthma.[11] Amgen terminated the agreement in 2014.[10]

As of 2014, there were reports that mogamulizimab can cause serious skin rashes and some cases of Stevens–Johnson syndrome.[11]

In 2017, the US FDA granted it a

priority review for CTCL.[12] Full approval was granted in August 2018.[6] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[13]

Research

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.[14]

References

  1. ^ a b "Poteligeo". Therapeutic Goods Administration (TGA). 15 February 2021. Retrieved 8 September 2021.
  2. ^ a b "AusPAR: Mogamulizumab". Therapeutic Goods Administration (TGA). 10 May 2021. Retrieved 8 September 2021.
  3. ^ "Poteligeo Product information". Health Canada. 25 April 2012. Retrieved 30 September 2022.
  4. ^ "Summary Basis of Decision - Poteligeo". Health Canada. 23 October 2014. Retrieved 28 November 2022.
  5. ^
    S2CID 3722081
    .
  6. ^ a b "FDA approves treatment for two rare types of non-Hodgkin lymphoma" (Press release).
  7. PMID 28946015
    .
  8. ^
    S2CID 24091636
    .
  9. ^ "Available Agents: Mogamulizumab". NCI Formulary. Retrieved 11 May 2018.
  10. ^ 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.
  11. ^
    S2CID 32596704
    .
  12. ^ Adamson L (22 January 2018). "Mogamulizumab Receives Priority Review for CTCL - ASH Clinical News". ASH Clinical News.
  13. ^ New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Retrieved 16 September 2020.
  14. PMID 29414279
    .

External links
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