Unituxin (dinutuximab) is a chimeric monoclonal antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG1 and light chain kappa. Unituxin binds to the glycolipid disialoganglioside (GD2). Dinutuximab is produced in the murine myeloma cell line, SP2/0.
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PARAMETER |
DATA |
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Manufacturer |
United Therapeutics Corp. |
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Indication |
Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. |
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Cell Substrate |
Glycosylated chimeric IgG1 human/mouse monoclonal antibody (mAb) |
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Manufacturing platform |
The upstream process consists of the thawing of a cell bank vial, cell expansion in a series of flasks, production in a bioreactor and recovery of the active substance. The active substance is purified with a series of chromatography, viral inactivation and filtration and ultra-/diafiltration steps. |
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Dose in vial/final container |
17.5 mg/5 mL (3.5 mg/mL) in a single-use vial |
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Dose to patient |
17.5 mg/m2 /day as a diluted intravenous infusion over 10 to 20 hours for 4 consecutive days for up to 5 cycles |
CLINICAL TRIALS:
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NCT |
TRIAL PHASE |
NO OF PATIENTS ENROLLED |
STUDY TITLE |
COUNTRIES |
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Clinical studies of ch14.18 in patients with Neuroblastoma |
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NCT03098030 |
2, 3 |
483 |
United States, India, Australia, Bulgaria, Italy, Canada, France, Georgia, Hong Kong, Poland, Taiwan, Romania, Korea, Republic of, Lithuania, Malaysia, Philippines, Russian Federation, Spain, Slovakia, Ukraine, Thailand, Hungary, United Kingdom |
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NCT00026312 |
3 |
1449 |
United States, Puerto Rico, Australia, New Zealand, Canada |
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NCT01041638 |
3 |
105 |
United States |
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NCT01418495 |
- |
12 |
Pharmacokinetics of Ch14.18 in Younger Patients with High-Risk Neuroblastoma |
United States |
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NCT01767194 |
2 |
73 |
United States, Puerto Rico, Australia, New Zealand, Canada |
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NCT01711554 |
1 |
27 |
United States, Canada |
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NCT01592045 |
1, 2 |
28 |
United States |
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March 10, 2015 |
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August 14, 2015 (withdrawn) |
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November 28, 2018 |
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March 17, 2020 (as Dinutuximab beta) |
This BLA for this new active moiety, first-in-class molecule was not referred for review to the Oncologic Drugs Advisory Committee (ODAC) for several reasons: the safety profile of dinutuximab is acceptable for the treatment of high-risk neuroblastoma, the evaluation of the safety data when used in the treatment of high-risk neuroblastoma did not raise significant safety or efficacy issues that were unexpected for a drug in this population, and the composition of the committee is predominantly adult oncologists who do not treat this disease. Instead, FDA sought advice from two pediatric oncologists and a patient representative as Special Government Employees, who concurred that substantial evidence of effectiveness had been demonstrated and the risk/benefit assessment was favorable in this life-threatening disease with no satisfactory alternative therapies.