Enasidenib mesylate is under clinical development by Bristol-Myers Squibb and currently in Phase III for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia). According to GlobalData, Phase III drugs for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) have a 38% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. 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 or relapsed and refractory AML (in the EU), and myelodysplastic syndrome (MDS), relapsed/ refractory multiple myeloma, chronic myelomonocytic leukemia (CMML), myeloproliferative neoplasm solid tumors, hepatic impairment.
It was also under development for non-Hodgkins T cell lymphoma, myeloproliferative disorders, angioimmunoblastic T-cell lymphoma (AITL), solid tumor and hematological tumor, type II D-2-hydroxyglutaric aciduria.
Bristol-Myers Squibb overview
Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in 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, cardiovascular, immunology and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities. BMS provides its products in the US, Europe, and Japan. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need. BMS is headquartered in New York City, New York, the US.
For a complete picture of Enasidenib mesylate’s drug-specific PTSR and LoA scores, buy the report here.