{"id":"mogamulizumab-kpkc","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":["6 ADVERSE REACTIONS 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. POTELIGEO was administered at 1 mg/kg intravenously 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 subsequent 28-day cycles. Premedication (diphenhydramine, acetaminophen) was optional and administered to 65% of randomized patients for the first infusion. The comparator group received vorinostat 400 mg orally once daily, given continuously in 28-day cycles. Treatment continued until unacceptable toxicity or progressive disease. The median age was 64 years (range, 25 to 101 years), 58% of patients were male, 70% were white, and 99% had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients had a median of 3 prior systemic therapies. The trial required an absolute neutrophil count (ANC) ≥1,500/µL (≥1,000/µL if bone marrow was involved), platelet count ≥100,000/µL (≥75,000/µL if bone marrow was involved), creatinine clearance >50 mL/min or serum creatinine ≤1.5 mg/dL, and hepatic transaminases ≤2.5 times upper limit of normal (ULN) (≤5 times ULN if lymphomatous liver infiltration). Patients with active autoimmune disease, active infection, autologous HSCT within 90 days, or prior allogeneic HSCT were excluded. During randomized treatment, the median duration of exposure to POTELIGEO was 5.6 months, with 48% (89/184) of patients with at least 6 months of exposure and 23% (43/184) with at least 12 months of exposure. The median duration of exposure to vorinostat was 2.8 months, with 22% (41/186) of patients with at least 6 months of exposure. Fatal adverse reactions within 90 days of the last dose occurred in 2.2% (7/319) of patients who received POTELIGEO as randomized or crossover treatment. Serious adverse reactions were reported in 36% (66/184) of patients randomized to POTELIGEO and most often involved infection (16% of patients; 30/184). Serious adverse reactions reported in >2% of patients randomized to POTELIGEO were pneumonia (5%), sepsis (4%), pyrexia (4%), and skin infection (3%); other serious adverse reactions, each reported in 2% of patients, included hepatitis, pneumonitis, rash, infusion related reaction, lower respiratory tract infection, and renal insufficiency. POTELIGEO was discontinued for adverse reactions in 18% of randomized patients, most often due to rash or drug eruption (7.1%). The most common adverse reactions (reported in ≥20% of patients random"],"contraindications":["4 CONTRAINDICATIONS None. None ( 4 )."]},"status":"discontinued","trials":["NCT04541017","NCT02301130","NCT02444793","NCT04185220","NCT05956041","NCT04745234","NCT06235281","NCT01611142","NCT05455931","NCT01728805","NCT04930653","NCT01626664","NCT04676087","NCT07132567","NCT03309878","NCT05996185","NCT04848064","NCT02358473"],"aliases":["POTELIGEO"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"brandName":"Mogamulizumab-Kpkc","companyId":"h-lee-moffitt-cancer-center-and-research-institute","ecosystem":[],"mechanism":{"target":"C-C chemokine receptor type 4","drugClass":"Chemokine Receptor Type 4 Interaction [EPC]","explanation":"1 INDICATIONS AND USAGE 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 ).","oneSentence":"12.1 Mechanism of Action 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. CCR4 is expressed on the surface of some T-cell malignancies and is expressed on regulatory T-cells (Treg) and a subset of Th2 T-cells."},"commercial":null,"references":[],"biosimilars":[],"companyName":"H. Lee Moffitt Cancer Center and Research Institute","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"},{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"Mogamulizumab-Kpkc","indications":{"approved":[{"name":"Mycosis fungoides","diseaseId":"mycosis-fungoides","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Peripheral T-cell lymphoma","diseaseId":"peripheral-t-cell-lymphoma","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Primary cutaneous T-cell lymphoma","diseaseId":"primary-cutaneous-t-cell-lymphoma","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04541017","phase":"Phase 1","title":"A Phase 1b/2 Study of Hu5F9-G4 (Magrolimab) in Combination With Mogamulizumab in Relapsed/Refractory Treated T-Cell Lymphoma","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","isPivotal":false,"enrollment":8,"indication":"Mycosis Fungoides, Recurrent Mycosis Fungoides","completionDate":"2024-10-24"},{"nctId":"NCT02301130","phase":"Phase 1","title":"Phase 1 Study of Mogamulizumab (KW-0761) in Combination With MEDI4736 (Durvalumab) and Mogamulizumab in Combination With Tremelimumab in Subjects With Advanced Solid Tumors","status":"COMPLETED","sponsor":"Kyowa Kirin, Inc.","isPivotal":false,"enrollment":64,"indication":"Advanced Solid Tumors","completionDate":"2018-03-05"},{"nctId":"NCT02444793","phase":"Phase 1","title":"A PHASE 1B STUDY OF PF-05082566 IN COMBINATION WITH MOGAMULIZUMAB (KW-0761) IN PATIENTS WITH ADVANCED SOLID TUMORS","status":"TERMINATED","sponsor":"Pfizer","isPivotal":false,"enrollment":24,"indication":"Advanced/Metastatic Solid Tumors","completionDate":"2017-10"},{"nctId":"NCT04185220","phase":"Phase 1","title":"Phase 1 Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for Patients With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","isPivotal":false,"enrollment":6,"indication":"Adult T-Cell Lymphoma/Leukemia, Sezary Syndrome","completionDate":"2022-05-18"},{"nctId":"NCT05956041","phase":"Phase 2","title":"A Phase II Study of Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas","status":"RECRUITING","sponsor":"University of Michigan Rogel Cancer Center","isPivotal":false,"enrollment":23,"indication":"Cutaneous T Cell Lymphoma, Fungoides Mycosis Sezary Syndrome","completionDate":"2027-04"},{"nctId":"NCT04745234","phase":"Phase 2","title":"Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants With Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kyowa Kirin, Inc.","isPivotal":false,"enrollment":34,"indication":"Cutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma Refractory","completionDate":"2025-05"},{"nctId":"NCT06235281","phase":"EARLY/Phase 1","title":"A Single-Arm, Open-Label, Pilot Study of Concurrent Phototherapy and POTELIGEO (Mogamulizumab-kpkc) in Early Stage Mycosis Fungoides (PLIGHT)","status":"SUSPENDED","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","isPivotal":false,"enrollment":20,"indication":"Mycosis Fungoides","completionDate":"2029-09-01"},{"nctId":"NCT01611142","phase":"Phase 2","title":"Open-Label, Multi-Center, Phase 2 Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","isPivotal":false,"enrollment":38,"indication":"Peripheral T-Cell Lymphoma","completionDate":"2015-05"},{"nctId":"NCT05455931","phase":"N/A","title":"Prospective Research Based Observational Study of Poteligeo® Experience in the Real World in Adult Patients With Mycosis Fungoides and Sézary Syndrome","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kyowa Kirin Pharmaceutical Development Ltd","isPivotal":false,"enrollment":73,"indication":"Mycosis Fungoides and Sézary Syndrome","completionDate":"2025-08-07"},{"nctId":"NCT01728805","phase":"Phase 3","title":"Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma","status":"COMPLETED","sponsor":"Kyowa Kirin, Inc.","isPivotal":true,"enrollment":372,"indication":"Cutaneous T-Cell Lymphoma","completionDate":"2021-02-17"},{"nctId":"NCT04930653","phase":"Phase 2","title":"A Phase II Study of Combination Extracorporeal Photopheresis (ECP) and Mogamulizumab in Erythrodermic CTCL","status":"RECRUITING","sponsor":"City of Hope Medical Center","isPivotal":false,"enrollment":34,"indication":"Folliculotropic Mycosis Fungoides, Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","completionDate":"2028-06-15"},{"nctId":"NCT01626664","phase":"Phase 2","title":"Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)","status":"COMPLETED","sponsor":"Kyowa Kirin, Inc.","isPivotal":false,"enrollment":71,"indication":"Adult T-cell Leukemia-Lymphoma","completionDate":"2018-02"},{"nctId":"NCT04676087","phase":"Phase 1","title":"Mogamulizumab and Extracorporeal Photopheresis (ECP) for the Treatment of Sézary Syndrome and Erythrodermic Mycosis Fungoides, a Phase 1b/2 Study","status":"TERMINATED","sponsor":"Emory University","isPivotal":false,"enrollment":5,"indication":"Mycosis Fungoides, Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","completionDate":"2023-10-11"},{"nctId":"NCT07132567","phase":"N/A","title":"Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance","status":"RECRUITING","sponsor":"Kyowa Kirin Co., Ltd.","isPivotal":false,"enrollment":15,"indication":"Mycosis Fungoides, Sezary Syndrome","completionDate":"2028-11"},{"nctId":"NCT03309878","phase":"Phase 1","title":"A Phase I and Randomized Phase II Study of KW-0761 (Mogamulizumab) and MK-3475 (Pembrolizumab) in Relapsed, Refractory Diffuse Large-B Cell Lymphoma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","isPivotal":false,"enrollment":8,"indication":"Recurrent Diffuse Large B-Cell Lymphoma, Recurrent High Grade B-Cell Lymphoma","completionDate":"2023-04-11"},{"nctId":"NCT05996185","phase":"Phase 2","title":"Phase II Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma","status":"RECRUITING","sponsor":"Yale University","isPivotal":false,"enrollment":22,"indication":"T Cell Lymphoma, T-cell Lymphoma","completionDate":"2027-11"},{"nctId":"NCT04848064","phase":"Phase 1","title":"A Pilot Phase I Trial of IL-21 Expanded, Off the Shelf, Third-Party Natural Killer (NK) Cells in Combination With Mogamulizumab in Patients With Cutaneous T-Cell Lymphomas or Adult T-Cell Leukemia/Lym","status":"RECRUITING","sponsor":"John Reneau","isPivotal":false,"enrollment":12,"indication":"Recurrent Adult T-Cell Leukemia/Lymphoma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","completionDate":"2027-01-30"},{"nctId":"NCT02358473","phase":"Phase 1","title":"Open-label, Multicenter Phase 1 Study of Mogamulizumab (KW-0761) in Combination With Docetaxel in Previously Treated Subjects With Non-small Cell Lung Cancer (NSCLC)","status":"COMPLETED","sponsor":"Kyowa Kirin, Inc.","isPivotal":false,"enrollment":13,"indication":"Non-Small Cell Lung Cancer","completionDate":"2016-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"INTRAVENOUS","dosage_text":"2 DOSAGE AND ADMINISTRATION 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. Infusion Reactions Permanently discontinue POTELIGEO for a life-threatening (Grade 4) infusion reaction [ see Warnings and Precautions (5.2) ]. Temporarily interrupt the infusion of POTELIGEO for mild to severe (Grades 1 to 3) infusion reactions and treat symptoms. Reduce the infusion rate by at least 50% when restarting the infusion after symptoms resolve. If reaction recurs and is unmanageable, discontinue infusion. [ see Warnings and Precautions (5.2) ]. If an infusion reaction occurs, administer premedication (such as diphenhydramine and acetaminophen) for subsequent POTELIGEO infusions. 2.3 Preparation and Administration Preparation Visually inspect drug product solution for particulate matter and discoloration prior to administration. POTELIGEO is a clear to slightly opalescent colorless solution. Discard the vial if cloudiness, discoloration, or particulates are observed. Calculate the dose (mg/kg) and number of vials of POTELIGEO needed to prepare the infusion solution based on patient weight. Aseptically withdraw the required volume of POTELIGEO into the syringe and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP. The final concentration of the diluted solution should be between 0.1 mg/mL to 3 mg/mL. Mix diluted solution by gentle inversion. Do not shake. Discard any unused portion left in the vial. The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags. Administration Administer infusion solution over at least 60 minutes through an intravenous line containing a sterile, low protein binding, 0.22 micron (or equivalent) in-line filter. Do not mix POTELIGEO with other drugs. Do not co-administer other drugs through the same intravenous line. Storage of Diluted Solution After preparation, infuse the POTELIGEO solution immediately, or store under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of infusion preparation. Do not freeze. Do not shake."},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","aiSummary":"","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}