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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

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:

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.