Mogamulizumab

Mogamulizumab-kpkc is a defucosylated, humanized IgG1 kappa monoclonal antibody that binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs. Non-clinical in vitro studies demonstrate mogamulizumab-kpkc binding targets a cell for antibody-dependent cellular cytotoxicity (ADCC) resulting in depletion of the target cells.

• POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. POTELIGEO is a CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy ( 1 ).

• None. None ( 4 ).contraindicated

1 mg/kg as an intravenous infusion over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle ( 2 ). 2.1 Recommended Dosage The recommended dose of POTELIGEO is 1 mg/kg administered as an intravenous infusion over at least 60 minutes. Administer on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity. Administer POTELIGEO within 2 days of the scheduled dose. If a dose is missed, administer the next dose as soon as possible and resume dosing schedule. Do not administer POTELIGEO subcutaneously or by rapid intravenous administration. Recommended Premedications Administer premedication with diphenhydramine and acetaminophen for the first POTELIGEO infusion. 2.2 Dose Modifications for Toxicity Dermatologic Toxicity Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) [ see Warnings and Precautions (5.1) ]. If SJS or TEN is suspected, stop POTELIGEO and do not resume unless SJS or TEN has been excluded and the cutaneous reaction has resolved to Grade 1 or less. If moderate or severe (Grades 2 or 3) rash occurs, interrupt POTELIGEO and administer at least 2 weeks of topical corticosteroids. If rash improves to Grade 1 or less, POTELIGEO may be resumed [ see Warnings and Precautions (5.1) ]. If mild (Grade 1) rash occurs, consider topical corticosteroids.

Dermatologic Toxicity : Temporarily interrupt POTELIGEO for moderate or severe skin rashes. Permanently discontinue POTELIGEO for life-threatening rash ( 5.1 ). Infusion Reactions : Temporarily interrupt POTELIGEO for any infusion reaction. Permanently discontinue POTELIGEO for any life-threatening infusion reaction ( 5.2 ). Infections : Monitor and treat promptly ( 5.3 ). Autoimmune Complications : Interrupt or permanently discontinue POTELIGEO as appropriate ( 5.4 ). Complications of Allogeneic HSCT after POTELIGEO : Monitor for severe acute graft-versus-host disease (GVHD) and steroid-refractory GVHD. Transplant-related mortality has occurred ( 5.5 ). 5.1 Dermatologic Toxicity Fatal and life-threatening skin adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have occurred in recipients of POTELIGEO. Rash (drug eruption) is one of the most common adverse reactions associated with POTELIGEO. In Study 0761-010, 25% (80/319) of patients treated with POTELIGEO had an adverse reaction of drug eruption, with 18% of these cases being severe (Grade 3) and 82% of these cases being Grade 1 or 2. Of 528 patients treated with POTELIGEO in clinical trials, Grade 3 skin adverse reactions were reported in 3.6%, Grade 4 skin adverse reactions in <1%, and SJS in <1%. The onset of drug eruption is variable, and the affected areas and appearance vary. In Study 0761-010, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Dermatologic Toxicity [ see Warnings and Precautions (5.1) ]. Infusion Reactions [ see Warnings and Precautions (5.2) ]. Infections [ see Warnings and Precautions (5.3) ]. Autoimmune Complications [ see Warnings and Precautions (5.4) ]. Complications of Allogeneic HSCT after POTELIGEO [ see Warnings and Precautions (5.5) ]. The most common adverse reactions (reported in ≥20% of patients) are rash, infusion related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to POTELIGEO in Study 0761-010, a randomized, open-label, actively controlled clinical trial for adult patients with MF or SS who received at least one prior systemic therapy [ see Clinical Studies (14) ]. Of 370 patients treated, 184 (57% with MF, 43% with SS) received POTELIGEO as randomized treatment and 186 (53% with MF, 47% with SS) received vorinostat. In the vorinostat arm, 135 patients (73%) subsequently crossed over to POTELIGEO for a total of 319 patients treated with POTELIGEO.

8.1 Pregnancy Risk Summary There are no available data on POTELIGEO use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In an animal reproduction study, administration of mogamulizumab-kpkc to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show a potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose, based on AUC ( see Data ). In general, IgG molecules are known to cross the placental barrier and in the monkey reproduction study mogamulizumab-kpkc was detected in fetal plasma. Therefore, POTELIGEO has the potential to be transmitted from the mother to the developing fetus. POTELIGEO is not recommended during pregnancy or in women of childbearing potential not using contraception. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

Metabolism

Mogamulizumab-kpkc pharmacokinetics (PK) was evaluated in patients with T-cell malignancies. Parameters are presented as the geometric mean [% coefficient of variation (%CV)] unless otherwise specified.

• Aug 8, 2018BLABLA761051Kyowa Kirin

1. 1Rash18214%
2. 2Disease Progression1138.9%
3. 3Drug Eruption735.7%
4. 4Pruritus655.1%
5. 5Infusion Related Reaction574.5%
6. 6Death483.8%
7. 7Fatigue463.6%
8. 8Pyrexia453.5%
9. 9Chills403.1%
10. 10Inappropriate Schedule Of Product Administration403.1%
11. 11Drug Ineffective372.9%
12. 12Erythema342.7%
13. 13Nausea272.1%
14. 14Skin Disorder272.1%
15. 15Condition Aggravated262.0%

The 10 most recently updated of 42 ClinicalTrials.gov registrations naming Mogamulizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma
  Completed · Observational · 100 enrolled · Fondazione Italiana Linfomi - ETS
  NCT06113081updated 2026-06-01
• Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas
  Recruiting · Phase 2 · Interventional · 23 enrolled · University of Michigan Rogel Cancer Center
  NCT05956041updated 2026-05-05
• Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma
  Recruiting · Phase 2 · Interventional · 22 enrolled · Yale University
  NCT05996185updated 2026-04-14
• A Study of VG712 in Patients With Mycosis Fungoides
  Not yet recruiting · Phase 2 · Interventional · 386 enrolled · Virogen Biotechnology Inc.
  NCT07529405updated 2026-04-14
• Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides
  Recruiting · Phase 1 · Interventional · 10 enrolled · University of Alabama at Birmingham
  NCT05414500updated 2026-04-09
• A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1
  Recruiting · Phase 2 · Interventional · 134 enrolled · Memorial Sloan Kettering Cancer Center
  NCT06698003updated 2026-03-05
• Phototherapy and Mogamulizumab in Early Stage MF (PLIGHT)
  Suspended · Early phase 1 · Interventional · 20 enrolled · H. Lee Moffitt Cancer Center and Research Institute
  NCT06235281updated 2026-02-27
• Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma
  Recruiting · Phase 1 · Interventional · 12 enrolled · John Reneau
  NCT04848064updated 2026-02-10
• Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment
  Terminated · Phase 1 · Phase 2 · Interventional · 8 enrolled · National Cancer Institute (NCI)
  NCT04541017updated 2025-10-16
• Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma
  Recruiting · Phase 2 · Interventional · 34 enrolled · City of Hope Medical Center
  NCT04930653updated 2025-10-14

Frequently asked questions

How does Mogamulizumab work?

Mogamulizumab-kpkc is a defucosylated, humanized IgG1 kappa monoclonal antibody that binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs. Non-clinical in vitro studies demonstrate mogamulizumab-kpkc binding targets a cell for antibody-dependent cellular cytotoxicity (ADCC) resulting in depletion of the target cells.

What is Mogamulizumab used for?

According to FDA labeling, Mogamulizumab carries indications including: POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. POTELIGEO is a CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Mogamulizumab?

Mogamulizumab is classified as Other monoclonal antibodies and antibody drug conjugates, Chemokine Receptor Type 4 Interaction, Monoclonal Antibody, Antibody-Receptor Interactions, Chemokine Receptor Type 4 Interactions, Increased Cellular Death.

What are the brand names for Mogamulizumab?

Mogamulizumab is marketed under brand names including Poteligeo.

What are the contraindications for Mogamulizumab?

Mogamulizumab labeling lists contraindications including: None. None ( 4 ).. Always consult the full prescribing information and a clinician.