Mogamulizumab

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Mogamulizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCCR4
Names
Pronunciationmoe gam" ue liz' ue mab
Trade namesPoteligeo
Other namesMogamulizumab-kpkc
Clinical data
Main usesMycosis fungoides, Sézary disease[1][2]
Side effectsRash, pneumonia, fever, cellulitis[2]
Pregnancy
category
Routes of
use
Intravenous
External links
AHFS/Drugs.comMonograph
US NLMMogamulizumab
MedlinePlusa618064
Legal
License data
Legal status
  • AU: S4 (Prescription only) [3][4]
  • US: ℞-only
  • In general: ℞ (Prescription only)
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 medication used to treat mycosis fungoides and Sézary disease.[1][2] It is used when other treatments are not effective.[1] It is given by gradual injection into a vein.[1]

Common side effects include rash, pneumonia, fever, and cellulitis.[2] Other side effects may include Stevens-Johnson syndrome, sepsis, pneumonitis, myocarditis, and polymyositis.[1] Use in pregnancy may harm the baby.[1] It is a monoclonal antibody that binds to CC chemokine receptor 4 (CCR4) found on white blood cells.[2]

Mogamulizumab was approved for medical use in the United States and Europe in 2018.[1][2] In the United Kingdom 4 mg cost the NHS about £1,300 as of 2021.[5] This amount in the United States costs about 4,200 USD.[6]

Medical uses

It was approved in Japan in 2012, for the treatment of relapsed or refractory CCR4+ adult T-cell leukemia/lymphoma (ATCLL) and in 2014, for relapsed or refractory CCR4+ cutaneous T cell lymphoma (CTCL).[7] The latter approval was based on study with 28 subjects.[8]

Dosage

It is given at a dose of 1 mg/kg once a week for 4 weeks than once every two weeks.[5]

History

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] [9] This is thought to enhance its antibody-dependent cell-mediated cytotoxicity.[10] It was first tested in humans in 2007.[9]

Kyowa licensed rights for use outside of cancer to Amgen in 2008, for $100 million up front and $420 million in biodollars.[11] Amgen ran a Phase I study to explore its use in asthma.[12] Amgen terminated the agreement in 2014.[11]

As of 2014, there were reports that mogamulizimab can cause serious skin rashes and some cases of Stevens–Johnson syndrome.[12]

In 2017, the US FDA granted it a priority review for CTCL.[13] Full approval was granted in August 2018.[14] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[15]

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.[16]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "Mogamulizumab-kpkc Monograph for Professionals". Drugs.com. Retrieved 18 November 2021.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 "Poteligeo". Retrieved 18 November 2021.
  3. 3.0 3.1 "Poteligeo". Therapeutic Goods Administration (TGA). 15 February 2021. Retrieved 8 September 2021.
  4. 4.0 4.1 "AusPAR: Mogamulizumab". Therapeutic Goods Administration (TGA). 10 May 2021. Retrieved 8 September 2021.
  5. 5.0 5.1 BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 920. ISBN 978-0857114105.
  6. "Poteligeo Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 18 November 2021.
  7. 7.0 7.1 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.
  8. 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.
  9. 9.0 9.1 Ueda R (2015). "Clinical Application of Anti-CCR4 Monoclonal Antibody". Oncology. 89 Suppl 1: 16–21. doi:10.1159/000431059. PMID 26550987. S2CID 24091636.
  10. "Available Agents: Mogamulizumab". NCI Formulary. Retrieved 11 May 2018.
  11. 11.0 11.1 Carroll J (August 25, 2017). "After a long clinical odyssey, the FDA tapped this PhIII anti-CCR4 as a 'breakthrough' lymphoma drug". Endpoints.
  12. 12.0 12.1 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.
  13. Adamson L (22 January 2018). "Mogamulizumab Receives Priority Review for CTCL - ASH Clinical News". ASH Clinical News.
  14. "FDA approves treatment for two rare types of non-Hodgkin lymphoma" (Press release).
  15. New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Retrieved 16 September 2020.
  16. 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.

External links

External sites:
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