Ivosidenib is under clinical development by Les Laboratoires Servier and currently in Phase II for Metastatic Bile Duct Cancer. According to GlobalData, Phase II drugs for Metastatic Bile Duct Cancer have a 71% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Ivosidenib’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.

Ivosidenib overview

Ivosidenib (Tibsovo / AG-120) acts as an anti-neoplastic agent. It is formulated as film-coated tablets, coated tablets for oral route of administration. Tibsovo is indicated for the treatment of relapsed or refractory acute myeloid leukemia in adults with a susceptible IDH1 mutation, and also for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. Tibsovo is indicated for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

AG-120 is under development for the treatment of myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML), clonal cytopenia of undetermined significance, metastatic bile duct cancer, advanced hematological malignancies including relapsed/primary refractory acute myeloid leukemia (AML), advanced solid tumors including glioma and chondrosarcoma. The drug candidate is administered through oral route. It acts by targeting isocitrate dehydrogenase 1.

Les Laboratoires Servier overview

Les Laboratoires Servier (Servier) researches, develops, manufactures, and markets drugs for treating various diseases. The company’s portfolio of marketed products treats central nervous system (CNS) disorders, cardiovascular diseases, cancer, ENT disorders, respiratory diseases, hematological disorders, hormonal disorders, and others. The company also provides generic drugs and contract development and manufacturing services across its global network. The company also provides digital therapeutic solutions through its e-health division, WeHealth Digital Medicine. It sells products in Europe, America, Middle East, Africa, and Asia. Servier headquartered in Suresnes, Ile-de-France, France.

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

This content was updated on 10 June 2024

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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.