Lumoxiti (moxetumomab pasudotox-tdf)

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

Company:

Approval Status:

Approved September 2018

Specific Treatments:

relapsed or refractory hairy cell leukemia

Therapeutic Areas

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General Information

Lumoxiti (moxetumomab pasudotox-tdf) is a CD22-directed cytotoxin.

Lumoxti is specifically indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

Lumoxiti is supplied as a solution for intravenous injection. The recommended dose of Lumoxiti is 0.04 mg/kg administered as a 30-minute intravenous infusion on Days 1, 3, and 5 of each 28-day cycle. Continue Lumoxiti treatment for a maximum of 6 cycles, disease progression, or unacceptable toxicity. 

Clinical Results

FDA Approval

The FDA approval of Lumoxiti was based on data from a Phase III single-arm, open-label trial of Lumoxiti monotherapy in 80 patients who had received at least two prior therapies, including a purine nucleoside analog.The primary endpoint of the trial was durable complete response. Moxetumomab pasudotox showed a 75% objective response (OR) rate, a 41% complete response (CR) rate, and a 30% durable CR rate (primary endpoint). The majority of patients with a complete response had a durable response (73%; 24/33) and achieved a negative minimal residual disease (MRD) status (82%; 27/33).

Side Effects

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

infusion related reactions

edema

nausea

fatigue

headache

pyrexia

constipation

anemia

diarrhea.

Most common laboratory abnormalities are creatinine increased, ALT increased, hypoalbuminemia, AST increased, hypocalcemia, and hypophosphatemia

The Lumoxiti drug label comes with the following Black Box Warning: Capillary Leak Syndrome (CLS), including life-threatening cases, occurred in patients receiving Lumoxiti. If CLS is suspected delay dosing or discontinue Lumoxiti. Hemolytic Uremic Syndrome (HUS), including life-threatening cases, occurred in patients receiving Lumoxiti. Monitor hemoglobin, platelet count, serum creatinine, and ensure adequate hydration. Discontinue Lumoxiti in patients with HUS.

Mechanism of Action

Lumoxiti (moxetumomab pasudotox-tdf) is a CD22-directed cytotoxin. Moxetumomab pasudotox-tdfk binds CD22 on the cell surface of B-cells and is internalized. Moxetumomab pasudotox-tdfk internalization results in ADP-ribosylation of elongation factor 2, inhibition of protein synthesis, and apoptotic cell death.

Additional Information

For additional information regarding Lumoxiti or relapsed or refractory hairy cell leukemia, please visit https://www.lumoxiti.com/patient.html