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.

Valemetostat overview

Valemetostat tosilate (Ezharmia) is an antineoplastic agent. It is formulated as film-coated tablets for the oral route of administration. Ezharmia is indicated for the treatment of patients with relapsed or refractory adult T-cell leukemia/lymphoma.

Valemetostat (DS-3201) is under development for the treatment of relapsed or refractory adult T-cell leukemia, T-cell lymphoma including peripheral T-cell lymphoma, primary mediastinal b-cell lymphoma, splenic marginal zone b-cell lymphoma, extranodal marginal zone b-cell lymphoma, non-hodgkin lymphoma, small cell lung cancer, metastatic urothelial carcinoma, metastatic castration-resistant prostate carcinoma, metastatic clear cell renal cell carcinoma, elapsed/refractory peripheral T-cell lymphoma (PTCL) including enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, primary cutaneous T-cell lymphoma, primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma, angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, nodal PTCL with T-follicular helper (TFH) phenotype, metastatic breast cancer and ALK positive, ALK negative anaplastic large cell lymphoma. The drug candidate is administered orally as a tablet or capsule. It targets the enzymes Histone-lysine N-methyl transferase EZH1 and EZH2.

It was under development for the treatment of relapsed or refractory acute myelocytic leukemia and acute lymphocytic leukemia.

Daiichi Sankyo overview

Daiichi Sankyo is a holding company, which carries out the research, development, manufacture, and marketing of pharmaceutical products. The company offers a wide range of prescription drugs, over the counter (OTC) drugs, vaccines, and others. Its portfolio encompasses medicines for cardiovascular, neurological, nephrological, diabetic, metabolic, and infectious diseases, and various types of cancers. Besides cancer, the company’s other research areas include rare diseases and immune disorders. Daiichi Sankyo sells its products through its group companies and an extensive network of medical representatives. It has operations in North America, South and Central America, Europe, and Asia. Daiichi Sankyo is headquartered in Tokyo, Japan.

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

This content was updated on 2 September 2023

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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.