BEDMINSTER, NJ, June 6, 2022--- Kyowa Kirin, Inc., (Kyowa Kirin, TSE: 4151) today announced that Health Canada has granted a Notice of Compliance to POTELIGEO® (mogamulizumab for injection) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. Taken together, MF and SS are the most common subtypes of cutaneous T-cell lymphoma (CTCL),i a rare form of lymphoma that can affect the skin, blood, lymph nodes, and internal organs.ii In Canada, the incidence rate of CTCL, which includes MF and SS among other types, is 11.32 cases per million individuals per year. Approximately 2,500 patients in Canada have been diagnosed with MF while about 110 have been diagnosed with SS.iii
POTELIGEO is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), which is a protein that is highly expressed on the surface of malignant T-cells in all patients with MF and SS, regardless of stage or skin and blood involvement. POTELIGEO was produced using Kyowa Kirin's proprietary POTELLIGENT® technology platform, which is associated with enhanced antibody-dependent cellular cytotoxicity.
Health Canada based its decision on clinical data from the MAVORIC trial, the largest clinical trial to date of a systemic treatment for MF and SS. Published in The Lancet in 2018, the MAVORIC trial was an open-label, international, phase 3, randomized controlled trial which demonstrated that patients in the POTELIGEO study arm met the primary endpoint of significantly prolonged progression-free survival compared with the active comparator treatment arm.iv The most common side effects of POTELIGEO include rash, infusion-related reactions, tiredness, diarrhea, muscle and bone pain, and upper respiratory tract infection. Safety information for POTELIGEO, including contraindications, additional warnings and precautions, adverse reactions and drug interactions is included in the Canadian product monograph.v
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan based global specialty pharmaceutical company with a more than 70-year heritage, the company applies cutting-edge science, including expertise in antibody research and engineering, to address the needs of patients across multiple therapeutic areas such as nephrology, oncology, immunology/allergy and neurology. Across its four regions – Japan, Asia Pacific, North America and EMEA/International – Kyowa Kirin focuses on its purpose, to make people smile, and is united by its shared values of commitment to life, teamwork, innovation, and integrity.
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- Olsen E, Vonderheid E, Pimpinelli N, et al. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood 2007; 110:1713.
- Cutaneous T-Cell Lymphoma. Leukemia & Lymphoma Society. https://www.lls.org/sites/default/les/le_assets/PS96_CTCL_Booklet_Final.pdf.
- Ghazawi FM, et al. Comprehensive analysis of cutaneous T-cell lymphoma (CTCL) incidence and mortality in Canada reveals changing trends and geographic clustering for this malignancy. Cancer. 2017;123(18):3550-3567.
- Kim, Youn Het al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. VOLUME 19, ISSUE 9, P1192-1204, SEPTEMBER 01, 2018.
- POTELIGEO® (mogamulizumab for injection) monograph. www.kyowakirin.ca.