Mogamulizumab
{{Short description|Monoclonal antibody}}
{{Use dmy dates|date=November 2022}}
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{{Infobox drug
| Verifiedfields = changed
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| verifiedrevid = 458284367
| type = mab
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| mab_type = mab
| source = zu/o
| target = CCR4
| pronounce = moe gam" ue liz' ue mab
| tradename = Poteligeo
| Drugs.com = {{drugs.com|monograph|mogamulizumab-kpkc}}
| MedlinePlus = a618064
| DailyMedID = Mogamulizumab
| pregnancy_AU = C
| pregnancy_category=
| routes_of_administration = Intravenous
| class = Antineoplastic agent
| ATC_prefix = L01
| ATC_suffix = FX09
| ATC_supplemental =
| legal_AU = S4
| legal_AU_comment = {{cite web | title=Poteligeo | website=Therapeutic Goods Administration (TGA) | date=15 February 2021 | url=https://www.tga.gov.au/apm-summary/poteligeo | access-date=8 September 2021 | archive-date=9 September 2021 | archive-url=https://web.archive.org/web/20210909020637/https://www.tga.gov.au/apm-summary/poteligeo | url-status=live }}{{cite web | title=AusPAR: Mogamulizumab | website=Therapeutic Goods Administration (TGA) | date=10 May 2021 | url=https://www.tga.gov.au/auspar/auspar-mogamulizumab | access-date=8 September 2021 | archive-date=9 September 2021 | archive-url=https://web.archive.org/web/20210909022206/https://www.tga.gov.au/auspar/auspar-mogamulizumab | url-status=live }}
| legal_BR =
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA_comment = /{{nbsp}}Schedule D{{cite web | title=Poteligeo Product information | website=Health Canada | date=25 April 2012 | url=https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=101691 | access-date=30 September 2022 | archive-date=1 October 2022 | archive-url=https://web.archive.org/web/20221001061313/https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=101691 | url-status=live }}{{cite web | title=Summary Basis of Decision - Poteligeo | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00611&lang=en | access-date=28 November 2022 | archive-date=28 November 2022 | archive-url=https://web.archive.org/web/20221128234231/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00611&lang=en | url-status=live }}
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| legal_US = Rx-only
| legal_EU = Rx-only
| legal_EU_comment = {{cite web | title=Poteligeo EPAR | website=European Medicines Agency (EMA) | date=14 October 2016 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/poteligeo | access-date=15 May 2024 | archive-date=5 July 2021 | archive-url=https://web.archive.org/web/20210705195900/https://www.ema.europa.eu/en/medicines/human/EPAR/poteligeo | url-status=live }}
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| legal_status = Rx-only
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| CAS_number_Ref = {{cascite|changed|??}}
| CAS_number = 1159266-37-1
| CAS_supplemental =
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB12498
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = YI437801BE
| KEGG_Ref = {{keggcite|changed|kegg}}
| KEGG = D09761
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| synonyms = mogamulizumab-kpkc
| C=6520 | H=10072 | N=1736 | O=2020 | S=42
}}
Mogamulizumab, sold under the brand name Poteligeo, is a humanized, afucosylated monoclonal antibody targeting CC chemokine receptor type 4 (CCR4).{{cite journal | vauthors = Yu X, Marshall MJ, Cragg MS, Crispin M | title = Improving Antibody-Based Cancer Therapeutics Through Glycan Engineering | journal = BioDrugs | volume = 31 | issue = 3 | pages = 151–166 | date = June 2017 | pmid = 28466278 | doi = 10.1007/s40259-017-0223-8 | s2cid = 3722081 | url = https://eprints.soton.ac.uk/410615/1/Resubmission_Yu_Manuscript_and_table.pdf | access-date = 15 May 2024 | archive-date = 26 August 2021 | archive-url = https://web.archive.org/web/20210826030905/https://eprints.soton.ac.uk/410615/1/Resubmission_Yu_Manuscript_and_table.pdf | url-status = live }} It is given by injection into a vein.
The most common side effects include rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection.
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. 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.{{cite report | title=New Drug Therapy Approvals 2018 | website=U.S. Food and Drug Administration (FDA) | date=January 2019 | url=https://www.fda.gov/media/120357/download | format=PDF | access-date=16 September 2020 | archive-date=17 September 2020 | archive-url=https://web.archive.org/web/20200917055627/https://www.fda.gov/media/120357/download | url-status=live }}
Medical uses
Mogamulizumab is indicated for the treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.
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.{{cite journal | vauthors = Ueda R | title = Clinical Application of Anti-CCR4 Monoclonal Antibody | journal = Oncology | volume = 89 | pages = 16–21 | date = 2015 | issue = Suppl 1 | pmid = 26550987 | doi = 10.1159/000431059 | s2cid = 24091636 }} This is thought to enhance its antibody-dependent cell-mediated cytotoxicity.{{cite web|title=Available Agents: Mogamulizumab|url=https://nciformulary.cancer.gov/available_agents/Mogamulizumab.htm|publisher=NCI Formulary|access-date=11 May 2018|archive-date=11 May 2018|archive-url=https://web.archive.org/web/20180511150233/https://nciformulary.cancer.gov/available_agents/Mogamulizumab.htm|url-status=live}} It was first tested in humans in 2007.
Kyowa licensed rights for use outside of cancer to Amgen in 2008, for $100 million up front and $420 million in biodollars. Amgen ran a Phase I study to explore its use in asthma.{{cite journal | vauthors = Pease JE, Horuk R | title = Recent progress in the development of antagonists to the chemokine receptors CCR3 and CCR4 | journal = Expert Opinion on Drug Discovery | volume = 9 | issue = 5 | pages = 467–83 | date = May 2014 | pmid = 24641500 | doi = 10.1517/17460441.2014.897324 | s2cid = 32596704 }} Amgen terminated the agreement in 2014.{{cite news|last1=Carroll|first1=John|title=After a long clinical odyssey, the FDA tapped this PhIII anti-CCR4 as a 'breakthrough' lymphoma drug|url=https://endpts.com/after-a-long-clinical-odyssey-the-fda-tapped-this-phiii-anti-ccr4-as-a-breakthrough-lymphoma-drug/|work=Endpoints|date=25 August 2017|access-date=11 May 2018|archive-date=31 October 2021|archive-url=https://web.archive.org/web/20211031111130/https://endpts.com/after-a-long-clinical-odyssey-the-fda-tapped-this-phiii-anti-ccr4-as-a-breakthrough-lymphoma-drug/|url-status=live}}
In 2017, the US FDA granted the application for mogamulizumab a priority review for cutaneous T cell lymphoma.{{cite news|last1=Adamson|first1=Laurie|title=Mogamulizumab Receives Priority Review for CTCL - ASH Clinical News|url=https://www.ashclinicalnews.org/news/mogamulizumab-receives-priority-review-ctcl/|work=ASH Clinical News|date=22 January 2018|access-date=10 May 2018|archive-date=10 May 2018|archive-url=https://web.archive.org/web/20180510121203/https://www.ashclinicalnews.org/news/mogamulizumab-receives-priority-review-ctcl/|url-status=live}} Full approval was granted by the FDA in August 2018. 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
= Legal status =
The US Food and Drug Administration (FDA) approved mogamulizumab in August 2018,{{cite web | title=Drug Approval Package: Poteligeo (mogamulizumab-kpkc) | website=U.S. Food and Drug Administration (FDA) | date=7 September 2018 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761051Orig1s000TOC.cfm | access-date=15 May 2024}} for the treatment of relapsed or refractory mycosis fungoides and Sézary disease.{{cite press release | title=FDA approves treatment for two rare types of non-Hodgkin lymphoma | website=U.S. Food and Drug Administration (FDA) | date=8 August 2018 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-two-rare-types-non-hodgkin-lymphoma | access-date=15 May 2024 | archive-date=15 July 2021 | archive-url=https://web.archive.org/web/20210715005552/https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-two-rare-types-non-hodgkin-lymphoma | url-status=live }} {{PD-notice}} 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. The latter approval was based on study with 28 participants.{{cite journal | vauthors = Broccoli A, Argnani L, Zinzani PL | title = Peripheral T-cell lymphomas: Focusing on novel agents in relapsed and refractory disease | journal = Cancer Treatment Reviews | volume = 60 | pages = 120–129 | date = November 2017 | pmid = 28946015 | doi = 10.1016/j.ctrv.2017.09.002 }}
Mogamulizumab was approved for medical use in the European Union in November 2018, and in Canada in June 2022.
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.{{cite journal | vauthors = Sato T, Coler-Reilly AL, Yagishita N, Araya N, Inoue E, Furuta R, Watanabe T, Uchimaru K, Matsuoka M, Matsumoto N, Hasegawa Y, Yamano Y | title = Mogamulizumab (Anti-CCR4) in HTLV-1-Associated Myelopathy | journal = The New England Journal of Medicine | volume = 378 | issue = 6 | pages = 529–538 | date = February 2018 | pmid = 29414279 | doi = 10.1056/NEJMoa1704827 | doi-access = free }}
References
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External links
- {{cite web | title=Mogamulizumab | website=National Cancer Institute | date=30 August 2018 | url=https://www.cancer.gov/about-cancer/treatment/drugs/mogamulizumabkpkc }}
- {{cite web | title=Mogamulizumab | work=NCI Drug Dictionary | publisher=National Cancer Institute | url=https://www.cancer.gov/publications/dictionaries/cancer-drug/def/mogamulizumab }}
{{Targeted cancer therapeutic agents}}
{{Monoclonals for tumors}}
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{{Chemokine receptor modulators}}
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