Poteligeo® (Mogamulizumab-kpkc) – 2018 FDA Approval

FDA Approval: 8/8/2018

Mogamulizumab-kpkc is a humanized monoclonal antibody developed by Kyowa Hakko Kirin Co., Ltd. for the treatment of cutaneous 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 indications on November 28, 2017, with an anticipated PDUFA date of June 4, 2018. Given the results of the MAVORIC study, the FDA approved mogamulizumab-kpkc for second line treatment of cutaneous T-cell lymphomas, Sezary Syndrome and Mycosis Fungoides, on August 8, 2018.

For our complete review of Mogamulizumab-kpkc (Poteligeo ®):

Executive Summary of Evaluation:

 

 

 

Indication

Mogamulizumab

(Kyowa Hakko Kirin Co., Ltd.)

Regulatory

 

Status

Marketed

PDUFA Cutaneous T-Cell Lymphoma

6/4/2018

  Orphan Drug Designation Cutaneous T-Cell Lymphoma

11/2/2010

  Peripheral T-Cell Lymphoma

11/2/2010

  T-Cell Leukemia; T-Cell Lymphomas

7/14/2011

  Breakthrough Therapy Designation Sezary Syndrome

8/25/2017

  Mycosis Fungoides

8/25/2017

  FDA Priority Review Cutaneous T-Cell Lymphoma

11/28/2017

  FDA Approval Sezary Syndrome

8/8/2018

  Mycosis Fungoides

8/8/2018

  Patent Expiration

1/11/2023

   
Indications Cutaneous T-Cell Lymphoma

Approved (BLA)

  Peripheral T-Cell Lymphoma

Inactive

  T-Cell Leukemia

Phase II

  T-Cell Lymphomas

Phase II

   
Efficacy  

Efficacy reported in Phase III Trials

 

References:

Clinical Trial data obtained at https://clinicaltrials.gov/ct2/home Accessed: August 10, 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: August 10, 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.

Additional 2018 Pipeline Reviews are available for the following drugs.

Moxetumomab pasudotox

Lanadelumab

Please see the July 2018 FDA Actions Newsletter for additional information on recent FDA approvals

Coauthored by: Kristen Ciampi, PharmD

Kristen recently graduated with a PharmD degree from the University of Rhode Island in May of 2018, and is a Pharmacy Analytics Intern at RJ Health Systems.