Enasidenib mesylate is under clinical development by Bristol-Myers Squibb 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 Enasidenib mesylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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.

Enasidenib mesylate overview

Enasidenib mesylate (CC-90007, AG-221, Idhifa) is an anti cancer agent. It is formulated as film coated tablets and tablets for oral route of administration. Idhifa is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.

It is under development for the treatment of clonal cytopenia of undetermined significance (CCUS), hematologic malignancies including untreated AML and myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), myeloproliferative neoplasm solid tumors, hepatic impairment and malignant sinonasal and skull base tumors.

It was also under development for relapsed and refractory AML, non-Hodgkins T cell lymphoma, myeloproliferative disorders, angioimmunoblastic T-cell lymphoma (AITL), solid tumor, relapsed/ refractory multiple myeloma and hematological tumor, type II D-2-hydroxyglutaric aciduria.

Bristol-Myers Squibb overview

Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company. It is engaged in the discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, immunology, cardiovascular, and fibrotic diseases. The company offers its products across the world to wholesalers, retail pharmacies, medical professionals, hospitals and government entities. The company has an operational presence in the US, Switzerland, Puerto Rico, Ireland, and the Netherlands. The company conducts research to focus on the discovery and development of novel medicines that address diseases in areas of unmet medical need. BMS is headquartered in Princeton, New Jersey, the US.

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

This content was updated on 12 April 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.