Dinutuximab beta is under clinical development by Recordati and currently in Phase II for Neuroblastoma. According to GlobalData, Phase II drugs for Neuroblastoma have a 21% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Dinutuximab beta’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 beta overview

Dinutuximab beta (APN-311, Isqette, Qarziba) is a chimeric monoclonal antibody. It is produced in Chinese hamster ovary (CHO) cells. It is formulated as concentrate solution and solution for intravenous route of administration. It is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Dinutuximab beta Apeiron should be combined with interleukin-2 (IL-2) in patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy.

Dinutuximab beta is under development for the treatment of leiomyosarcoma. It was under development for neuroblastoma in the U.S, Japan and other countries and also for other GD2 indications.

Recordati overview

Recordati, a subsidiary of Fimei SpA, is a pharmaceutical company that researches, develops, manufactures and markets pharmaceuticals. The company offers pharmaceuticals for cardiovascular diseases, central nervous system disorders, dermatology, musculoskeletal disorders and analgesia, and urology diseases. It also offers cosmetics, dietary supplements, pregnancy test products, over-the-counter (OTC) and non-prescription pharmaceuticals, anti-infectives, and others. It manufactures pharmaceutical chemicals such as active pharmaceutical ingredients (APIs) and intermediates. The company sells its pharmaceuticals directly in the countries of its operations and through licensees in other places. Recordati is headquartered in Milan, Italy.

For a complete picture of Dinutuximab beta’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.