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Poteligeo FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved August 8, 2018)
Brand name: Poteligeo
Generic name: mogamulizumab-kpkc
Dosage form: Injection
Company: Kyowa Kirin, Inc.
Treatment for: Mycosis Fungoides; Sézary Syndrome

Poteligeo (mogamulizumab-kpkc) is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma (CTCL).

Dosage Forms and Strengths

  • Injection: 20 mg/5 mL (4 mg/mL) solution in a single-dose vial.

Dosage and Administration

Poteligeo is administered 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.

Warnings and Precautions

Poteligeo may cause serious side effects that can be severe or life-threatening. The following adverse reactions may require additional treatment and/or withholding or discontinuation of Poteligeo:

  • Dermatological Toxicity: Patients need to contact their healthcare provider immediately if they experience new or worsening skin rash. Treatment should be temporarily interrupted for moderate or severe skin rashes and permanently discontinued for a life-threatening rash.
  • Infusion Reactions: Patients need to contact their healthcare provider immediately for signs or symptoms of infusion reactions. Treatment should be temporarily interrupted for any infusion reaction and permanently discontinued for any life-threatening infusion reaction.
  • Infections: Patients need to contact their healthcare provider if they experience fever or other signs of infection. Infections should be monitored and treated promptly.
  • Autoimmune Complications: Patients need to notify their healthcare provider of any history of autoimmune disease. Treatment should be interrupted or permanently discontinued as appropriate.
  • Complications of Allogeneic Hematopoietic Stem Cell Transplantation after Poteligeo: Patients need to be aware of the potential risk of post-transplant complications. Patients should be monitored for severe acute graft-versus-host disease (GVHD) and steroid-refractory GVHD.
  • Females of Reproductive Potential: Females who are able to become pregnant should use an effective method of birth control during treatment with Poteligeo and for at least three months after the last dose.

Adverse Reactions

The most common adverse reactions (reported in ≥20% of patients) were rash, infusion related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection.

Development Timeline for Poteligeo

Aug  8, 2018Approval  FDA Approves Poteligeo (mogamulizumab-kpkc) for Mycosis Fungoides and Sézary Syndrome
May 30, 2018Kyowa Hakko Kirin Announces FDA Notification of PDUFA Action Date Extension for Mogamulizumab
Nov 28, 2017Kyowa Hakko Kirin Announces FDA Acceptance for Filing and Priority Review Designation of Mogamulizumab Biologics License Application
Aug 25, 2017FDA Grants Breakthrough Therapy Designation for Mogamulizumab for the Treatment of Mycosis Fungoides and Sézary Syndrome

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.