Poteligeo (mogamulizumab-kpkc)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved August 2018

Specific Treatments:

mycosis fungoides or Sézary syndrome

Therapeutic Areas

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General Information

Poteligeo (mogamulizumab-kpkc) is a monoclonal antibody that binds to a protein (called CC chemokine receptor type 4 or CCR4) found on some cancer cells. 

Poteligeo is specifically indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. 

Poteligeo is supplied as a solution for intravenous administration. The recommended dose is 1 mg/kg administered as an intravenous infusion over at least 60 minutes. Administer on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity. Administer Poteligeo within 2 days of the scheduled dose. If a dose is missed, administer the next dose as soon as possible and resume dosing schedule. Do not administer Poteligeo subcutaneously or by rapid intravenous administration. 

Clinical Results

FDA Approval

The FDA approval of Poteligeo was based on a clinical trial of 372 patients with relapsed MF or SS who received either Poteligeo or vorinostat. The dose of Poteligeo was 1 mg/kg administered intravenously 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. Vorinostat was dosed at 400 mg orally once daily, continuously for 28-day cycles. Treatment continued until disease progression or unacceptable toxicity. Progression-free survival was longer for patients taking Poteligeo (median 7.6 months) compared to patients taking vorinostat (median 3.1 months).

Side Effects

Adverse effects associated with the use of Poteligeo may include, but are not limited to, the following:

rash

infusion related reactions

fatigue

diarrhea

musculoskeletal pain

upper respiratory tract infection

Mechanism of Action

Poteligeo (mogamulizumab-kpkc) is a defucosylated, humanized IgG1 kappa monoclonal antibody that binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs. Non-clinical in vitro studies demonstrate mogamulizumab-kpkc binding targets a cell for antibody-dependent cellular cytotoxicity (ADCC) resulting in depletion of the target cells. CCR4 is expressed on the surface of some Tcell malignancies and is expressed on regulatory T-cells (Treg) and a subset of Th2 T-cells.

Additional Information

For additional information regarding Poteligeo or mycosis fungoides or Sézary syndrome, please visit https://poteligeo.com/