Dinutuximab is under clinical development by United Therapeutics and currently in Phase II for Osteosarcoma. According to GlobalData, Phase II drugs for Osteosarcoma have a 13% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Dinutuximab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Dinutuximab overview

Dinutuximab (Unituxin) is a chimeric monoclonal antibody, composed of a combination of mouse and human DNA acts as an anti-neoplastic agent. It is formulated as solution, concentrate solution for intravenous or Intravenous drip route of administration. Unituxin is indicated in combination with granulocyte-macrophage colonystimulating 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.

Dinutuximab is under development for the treatment of osteosarcoma. It was also under development for relapsed and refractory small-cell lung cancer.

United Therapeutics overview

United Therapeutics develops and commercializes innovative pharmaceutical products for the treatment of cardiovascular disorders, particularly pulmonary arterial hypertension, and infectious diseases. The company’s products consist of prostacyclin analogs including Remodulin (treprostinil) injection; Tyvaso (treprostinil) inhalation solution; and Orenitram (treprostinil). Adcirca (tadalafil) is a phosphodiesterase type 5 (PDE-5) inhibitor and Unituxin (dinutuximab), a monoclonal antibody for oncologic applications, are the other products. Its product candidates include monoclonal antibodies (mAbs), glycobiology antiviral agents, and cell-based therapies. The company also develops engineered lungs for transplantation in the pre-clinical stage. It manufactures products in its facility in Silver Spring, Maryland. It markets its products in the US, Europe, South America, and Israel. United Therapeutics is headquartered in Silver Spring, Maryland, the US.

For a complete picture of Dinutuximab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 7 February 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.