Lumoxiti (moxetumomab pasudotox-tdf)

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


Approval Status:

Approved September 2018

Specific Treatments:

relapsed or refractory hairy cell leukemia

Therapeutic Areas

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









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


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