Poteligeo
Relapsed or refractory mycosis fungoides (MF) or SΓ©zary syndrome (SS) in adults who have received at least one prior systemic therapy.
1 mg/kg IV over at least 60 minutes
Cycle 1: Days 1, 8, 15, 22 of 28-day cycle
Cycle 2+: Days 1 and 15 of each 28-day cycle
Continue until disease progression or unacceptable toxicity
Injection: 20 mg/5 mL (4 mg/mL) single-dose vial
None listed.
- Dermatologic Toxicity: Skin reactions in 35% (Grade 3 in 5%). Drug rash, dermatitis, eczema. Can be difficult to distinguish from underlying disease. May require biopsy.
- Infusion-Related Reactions: In 35% (Grade 3 in 3%). Most during/after first infusion. Pre-medicate with diphenhydramine and acetaminophen.
- Infections: Serious infections in 19% (fatal in 1%). Viral reactivation (HSV, HBV) reported.
- Autoimmune Complications: Polymyositis, autoimmune hepatitis, pneumonitis reported due to T-reg depletion.
- Complications of Allogeneic HSCT: Increased risk of transplant complications (severe GVHD, steroid-requiring febrile syndrome, hepatic VOD) if mogamulizumab given before allo-HSCT.
Rash (35%), infusion-related reactions (35%), fatigue (28%), diarrhea (23%), musculoskeletal pain (19%), upper respiratory tract infection (17%), drug eruption (14%), pyrexia (14%), headache (11%), peripheral edema (11%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Mogamulizumab is a humanized IgG1ΞΊ monoclonal antibody with a defucosylated Fc region that binds to CC chemokine receptor 4 (CCR4). CCR4 is preferentially expressed on malignant T cells in cutaneous T-cell lymphomas (CTCL), particularly in SΓ©zary syndrome. The defucosylated Fc provides enhanced antibody-dependent cellular cytotoxicity (ADCC) against CCR4-positive malignant cells. CCR4 is also expressed on regulatory T cells (Tregs), so depletion of Tregs may contribute to additional anti-tumor immune responses.
Half-life: approximately 17 days. Steady-state by Cycle 3. Non-linear PK with target-mediated drug disposition at lower concentrations. Clearance: 0.37 L/day. Vd: 5.7 L.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
- MAVORIC β Mogamulizumab vs. vorinostat in relapsed/refractory CTCL. Phase III, n=372.