Mogamulizumab is a humanized monoclonal antibody being developed by Kyowa Hakko Kirin Co., Ltd. for the treatment of cutaneous and peripheral T-cell lymphomas, T-cell leukemia, and T-cell lymphomas. Mogamulizumab has shown promising efficacy in treating Cutaneous T-Cell Lymphoma (CTCL) in a phase III trial. The FDA granted mogamulizumab a Breakthrough Therapy Designation on August 25, 2017 for the treatment of Sezary Syndrome and Mycosis Fungoides. The drug candidate was also granted Priority Review for its cutaneous T-cell lymphoma indication on November 28, 2017, with an anticipated PDUFA date of June 4, 2018. Given the results of the MAVORIC study, it is anticipated that the FDA will approve mogamulizumab for second line treatment of cutaneous T-cell lymphomas before the end of June this year.
For our complete review of Mogamulizumab:
(Kyowa Hakko Kirin Co., Ltd.)
|PDUFA||Cutaneous T-Cell Lymphoma||
|Orphan Drug Designation||Cutaneous T-Cell Lymphoma||
|Peripheral T-Cell Lymphoma||
|T-Cell Leukemia; T-Cell Lymphomas||
|Breakthrough Therapy Designation||Sezary Syndrome||
|FDA Priority Review||Cutaneous T-Cell Lymphoma||
|Indications||Cutaneous T-Cell Lymphoma||
Submitted for Approval (BLA)
|Peripheral T-Cell Lymphoma|
Efficacy reported in Phase III Trials
Clinical Trial data obtained at https://clinicaltrials.gov/ct2/home Accessed: March 15, 2018.
Korgavkar K, Xiong M, Weinstock M. Changing Incidence Trends of Cutaneous T-Cell Lymphoma. JAMA Dermatol. 2013;149(11):1295-1299.
Pharma Intelligence Center https://pharma.globaldata.com Accessed: March 13, 2018.
Wang SS, Vose JM. Epidemiology and prognosis of T-cell lymphoma. T-Cell Lymphomas (pp. 25-39). Humana Press Inc.
Lymphoma Research Foundation. Getting the Facts Cutaneous T-Cell Lymphoma. https://www.lymphoma.org/wp-content/uploads/2017/06/LRF_FACTSHEET_Cutaneous_TCell_Lymphoma_CTCL.pdf Last Updated August 2017 Accessed: March 27, 2018.
On August 8, 2018 the FDA approved mogamulizumab-kpkc (Poteligeo ®) for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. The original PDUFA date of June 4, 2018 had been extended to September 4, 2018 due to additional documentation related to the manufacturing section of the BLA submitted by Kyowa Hakko Kirin during the review process.
Pharma Intelligence Center https://pharma.globaldata.com Accessed: August 8, 2018.
Additional 2018 Pipeline Reviews are available for the following drugs.
For an overview of FDA PDUFA dates as of March 2018 click here.
Coauthored by: Kristen Ciampi, PharmD Candidate
Kristen is a sixth-year pharmacy student at the University of Rhode Island. Kristen is completing her studies through an advanced pharmacy practice rotation at RJ Health Systems prior to graduating with a PharmD degree in May of 2018.