Poteligeo (mogamulizumab-kpkc) / Kyowa Kirin, Swixx BioPharma - LARVOL DELTA

When Thyroiditis Meets Grave's: Untangling the Mystery of Atypical Hyperthyroidism (ENDO 2025) - "This case highlights the challenges of hyperthyroidism in a patient lacking classic features of either condition.Case PresentationA 50-year-old woman with cutaneous T-cell non-Hodgkin lymphoma (in remission, treated with mogamulizumab since 2020, currently on weekly therapy), untreated subclinical hyperthyroidism, and hypertension presented with fatigue, weakness, and a viral illness 8 weeks prior.Initial evaluation revealed undetectable TSH (6.0 ng/dL, and elevated C-reactive protein (CRP) at 6.80 mg/dL, consistent with thyrotoxicosis...However, the elevated TRAbs suggested underlying Graves' disease, prompting methimazole initiation.DiscussionDistinguishing SAT from Graves' disease requires careful integration of clinical, laboratory, and imaging findings:SAT: Low iodine uptake, elevated inflammatory markers (e.g., CRP), preceding viral illness, and normal or decreased vascularity on Doppler ultrasound.Graves' disease: High iodine uptake, positive TRAbs,..."

Cardiovascular • Cutaneous T-cell Lymphoma • Endocrine Disorders • Fatigue • Grave’s Disease • Hematological Malignancies • Hypertension • Immunology • Infectious Disease • Lymphoma • Musculoskeletal Pain • Non-Hodgkin’s Lymphoma • Oncology • Pain • T Cell Non-Hodgkin Lymphoma • CRP

Efficacy and manageable toxicity of mogamulizumab in a real-world North American cohort of adult T-cell leukemia/lymphoma (ATLL). (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Real-world • Real-world evidence • Adult T-Cell Leukemia-Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

“Update of section 4.8 of the SmPC in order to add 'granuloma' to the list of adverse drug reactions (ADRs) with frequency 'unknown', based on post marketing data; the Package Leaflet is updated accordingly” (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC)-Draft agenda for the meeting on 7 - 10 Apr 2025: “For adoption of PRAC Assessment Report”

PRAC • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Evaluation of the anti-CCR4 monoclonal antibody Mogamulizumab in advanced cutaneous T-cell lymphomas and with large cell transformation. (PubMed, Br J Dermatol) - No abstract available

Journal • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CCR4

Phase I study on neoadjuvant combination immunotherapy with mogamulizumab and nivolumab for solid tumors. (PubMed, J Immunother Cancer) - P1 | "The preoperative combination of mogamulizumab and nivolumab was safely managed, exerted antitumor effects, and may be an effective option in the preoperative setting."

Journal • P1 data • Esophageal Cancer • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Oncology • Oral Cancer • Pneumonia • Respiratory Diseases • Solid Tumor • CCR4 • FOXP3

Effects of tucidinostat in adult T-cell leukemia/lymphoma in clinical practice. (PubMed, Int J Hematol) - "Between October 2021 and July 2023, 24 patients aged 41 to 88 years (median, 73.4 years) who had undergone prior therapies, including intensive chemotherapy (79.2%) and mogamulizumab immunotherapy (79.2%), received tucidinostat. Treatment-related adverse events were mainly hematologic but were managed over the course of treatment. Our findings indicate that tucidinostat provides survival benefits in patients with relapsed/refractory ATL in clinical practice and highlight key clinical factors for better outcomes."

Journal • Adult T-Cell Leukemia-Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • IL2

Government of Canada signs bilateral agreement with Nova Scotia to improve access to drugs for rare diseases (Yahoo Finance) - "The first step in this bilateral agreement will be to deliver funding to support the province for the following...drugs under the National Strategy for Drugs for Rare Diseases: Poteligeo, for the treatment of mycosis fungoides or Sézary syndrome...Epkinly for relapsed or refractory diffuse large B-cell lymphoma; Welireg for the treatment of treatment of von Hippel-Lindau (VHL) disease; Yescarta for the treatment of follicular lymphoma, large B-cell lymphoma (LBCL), diffuse large B-cell lymphoma (DLBCL), and high-grade B-cell lymphoma (HGBL); and, Koselugo, for the treatment of neurofibromatosis type 1."

Reimbursement • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Neurofibromatosis • Sezary Syndrome • Von Hippel-Lindau Syndrome

Therapeutic advances for Cutaneous T Cell Lymphoma. (PubMed, Br J Dermatol) - "Brentuximab vedotin is very efficient for tumor and transformed MF. Mogamulizumab can induce long term remission in patients with SS. Lacutamab has recently completed an international trial, both in SS and MF...Kinase inhibitors and Chimeric Antigen Receptor (CAR)-T Therapy are promising new treatments. Finally, recent studies have demonstrated that allogeneic hematopoietic stem-cell transplantation can increase survival and quality of life in patients with advanced CTCL."

Journal • Bone Marrow Transplantation • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • Transplantation

Systemic Targeted Therapies in Patients with Relapsed/Refractory Advanced Stage Cutaneous T-cell Lymphoma: A Real-world Single-centre Case Series. (PubMed, Acta Derm Venereol) - "Early stages are often controlled with skin-directed therapy, such as topical corticosteroids, topical chlormethine gel, or UV therapy, whereas advanced stages often warrant a more aggressive approach with systemic antibody targeted therapy including mogamulizumab, brentuximab vedotin, or alemtuzumab. Median time to progression was 2.5, 4, and 11 months, respectively. In conclusion, this paper offers a unique perspective on the complexities of clinical practice when managing advanced-stage cutaneous T-cell lymphomas and demonstrates the effectiveness of the therapies described, with particular emphasis on the promising results observed with alemtuzumab administered in a low-dose protocol."

Journal • Real-world evidence • Retrospective data • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Clinical and therapeutic significance of genetic profiling in adult T-cell leukemia/lymphoma. (PubMed, Leuk Res) - "Furthermore, genetic and epigenetic events influencing response to molecularly targeted therapies, such as mogamulizumab and valemetostat, have also been identified. Collectively, these insights underscore the clinical importance of assessing genetic alterations. This review highlights the latest insights into the genetic landscape of ATLL and their clinical implications, which will facilitate the development of future strategies for targeted and personalized therapy."

IO biomarker • Journal • Review • Adult T-Cell Leukemia-Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • PD-L1 • PRKCB

A Retrospective Cohort Study: The Safety and Feasibility of Infusing Biological Medications in a Dermatology Practice (AAD 2025) - "Our office, directed by a single physician in general dermatology practice and dermatologic surgery, has routinely administered infliximab, rituximab, cemiplimab, and mogamulizumab in the office with positive outcomes. Pre-medicating patients mitigated most reactions, with manageable symptoms like headache and fatigue. Our findings demonstrate that intravenous (IV) infusion medications can be safely administered within the dermatology office setting, providing an all-inclusive and convenient option for patient care in the dermatology practice."

Retrospective data • Dermatology • Fatigue • Immunology • Inflammatory Arthritis • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Pruritus • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Urticaria

Cutaneous T-cell lymphomas: a real-life experience of anticipated use of mogamulizumab in Italy. (PubMed, Ital J Dermatol Venerol) - "The most recent Guidelines confirm this approach, but recommend also an anticipated use (starting from the second line) of new therapeutic agents in advanced skin lymphomas. In this report, we discuss eight cases of patients with mycosis fungoides or Sézary Syndrome successfully managed with an anticipated use of mogamulizumab in real-life clinical practice in Italy."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1 (clinicaltrials.gov) - P2 | N=134 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | N=200 ➔ 134

Enrollment change • Adult T-Cell Leukemia-Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: John Reneau | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Adult T-Cell Leukemia-Lymphoma • B Cell Lymphoma • Cutaneous T-cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Safety Outcomes of a One-Bag Chemotherapy/Monoclonal Desensitization Protocol and Outpatient Transition (AAAAI-WAO 2025) - "Medications completed as 1BP included oxaliplatin, carboplatin, irinotecan, paclitaxel, doxorubicin, and several monoclonal antibodies including nivolumab, mogamulizumab, brentuximab, pembrolizumab and trastuzumab. Conclusions Low risk patients requiring inpatient MBP desensitization were safely transitioned to outpatient 1BP for multiple chemotherapeutics and monoclonal antibodies. Patients selected for outpatient 1BP had fewer reactions, demonstrating sound patient selection without safety loss."

Clinical • Allergy • Immunology

Successful treatment with EPOCH followed by mogamulizumab for angioimmunoblastic T-cell lymphoma with myelofibrosis and pure red cell aplasia (PubMed, Rinsho Ketsueki) - "Complete remission was maintained for five years. This indicates that EPOCH and mogamulizumab are treatment options for AITL patients with bone marrow involvement, PRCA, and myelofibrosis."

Journal • Fibrosis • Hematological Disorders • Hematological Malignancies • Immunology • Lymphoma • Myelofibrosis • Non-Hodgkin’s Lymphoma • Oncology • Otorhinolaryngology • T Cell Non-Hodgkin Lymphoma

Targeted antibody therapy as a treatment strategy for aggressive adult T-cell leukemia/lymphoma. (PubMed, Leuk Res) - "The advent of the anti-CC chemokine receptor 4 (CCR4) antibody mogamulizumab has significantly advanced ATL treatment...In addition, emerging immunotherapies, including Tax peptide dendritic cell vaccines, immune checkpoint inhibitors, and Chimeric Antigen Receptor-T cell therapy, are under investigation. These innovative approaches aim to enhance immunogenic responses and offer hope for better outcomes in this challenging malignancy."

IO biomarker • Journal • Adult T-Cell Leukemia-Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCR4

Orphan Drug Designations and Approvals (FDA) - Generic Name: mogamulizumab, Trade Name: POTELIGEO, Date Designated: 11/02/2010, Orphan Designation: Treatment of patients with cutaneous T-cell lymphoma, Orphan Designation Status: Designated/Approved

Orphan drug • Cutaneous T-cell Lymphoma

Union Register of medicinal products for human use (European Commission) - Product name: ACTIVEPoteligeo, EU number: EU/1/18/1335, Active substance: Mogamulizumab, Related orphan designation(s): Orphan market exclusivity for "Treatment of cutaneous T-cell lymphoma" (based on designation EU/3/16/1756) started on 26 Nov 2018, 10 years of market exclusivity. This orphan market exclusivity will expire on 26 Nov 2028

Orphan drug • Cutaneous T-cell Lymphoma

Approval for Additional Indication for Chemotherapy-Native CCR4-positive ATL of Mogamulizumab (Kyowa Hakko Kirin Pharma Press Release) - "Mogamulizumab was also granted orphan drug designations for the treatment of CCR4-positive ATL in August 2010 and PTCL/CTCL in March 2013 by the MHLW."

Orphan drug • Hematological Malignancies

Australian Public Assessment Report for Mogamulizumab (Australian Government Department of Health) - "Approved therapeutic use: Treatment of adult patients (≥ 18 years of age) with Mycosis Fungoides (MF) or Sézary Syndrome (SS) who have received at least one prior systemic therapy."

Orphan drug • Mycosis Fungoides • Sezary Syndrome

US Food and Drug Administration Grants Breakthrough Therapy Designation for Mogamulizumab for the treatment of Mycosis Fungoides and Sézary Syndrome (Kyowa Hakko Kirin Pharma Press Release) - "Kyowa Hakko Kirin...announced that U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to their investigational product, mogamulizumab which is being developed for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), in adult patients who have received at least one prior systemic therapy. Mycosis Fungoides and Sézary Syndrome are the most common subtypes of cutaneous T-cell lymphoma (CTCL)."

Breakthrough therapy • Mycosis Fungoides • Sezary Syndrome

Kyowa Kirin and Swixx BioPharma announce expansion of access to POTELIGEO (mogamulizumab) for adults living with mycosis fungoides or Sézary syndrome in Central and Eastern Europe (Businesswire) - "Kyowa Kirin International...and Swixx BioPharma AG today announced that the Croatian National Health Insurance Fund (NHIF) and the Bulgarian Ministry of Health have both approved the reimbursement of POTELIGEO (mogamulizumab) for adult patients with mycosis fungoides (MF), and Sézary syndrome (SS)....With Croatian reimbursement effective as of 15th November 2024, and Bulgaria’s Ministry of Health confirming reimbursement as of 2nd January 2025, both decisions build on the inclusion of POTELIGEO (mogamulizumab) in the Polish Ministry of Health’s Drug Programme announced in July 2024 and the ongoing expansion of access to patients across Central and Eastern Europe (CEE)."

Reimbursement • Mycosis Fungoides • Sezary Syndrome

A CASE OF THROMBOTIC MICROANGIOPATHY IN LUPUS NEPHRITIS FOLLOWING TREATMENT WITH MOGAMULIZUMAB, ANTI-CCR4 ANTIBODY, FOR ADULT T CELL LEUKEMIA (ISN-WCN 2025) - "Bone marrow biopsy revealed hypocellular bone marrow, then we stopped PE and she was treated with eltrombopag and red blood cell transfusion. On this point, a previous report showed PE decreased the plasma concentration of mogamulizumab but PE did not lead to the quick recovery of Treg cells. Conclusions Further investigation about the pathological effect of mogamulizumab therapy on disease activity in SLE and effective treatment for disease exacerbation should be needed."

Clinical • Adult T-Cell Leukemia-Lymphoma • Anemia • Glomerulonephritis • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Leukemia • Lupus • Lupus Nephritis • Nephrology • Oncology • Thrombocytopenia • CCR4

Significant detrimental impact of pre-transplant mogamulizumab on the post-transplant outcome with a short interval between the last mogamulizumab and transplantation. (PubMed, Bone Marrow Transplant) - No abstract available

Journal • Transplantation