Romidepsin is under clinical development by Bristol-Myers Squibb and currently in Phase II for Anaplastic Large Cell Lymphoma (ALCL). According to GlobalData, Phase II drugs for Anaplastic Large Cell Lymphoma (ALCL) have a 29% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Romidepsin’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.

Romidepsin overview

Romidepsin (Istodax) is an antineoplastic agent. It is formulated as lyophilized powder for solution for intravenous administration. Istodax is approved for the treatment of cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior systemic therapy.

Romidepsin (FR901228, FK228, Depsipeptide) is under development for the treatment of peripheral T-cell lymphoma (first line), advanced pancreatic ductal adenocarcinoma (first line), lymphoma, chronic lymphocytic leukemia (CLL), solid tumor like prostate cancer, pancreatic cancer, lung cancer, colorectal cancer, hepatocellular carcinoma, soft tissue sarcoma, glioma, neuroendocrine tumor, breast cancer, thyroid cancer, bladder cancer, head and neck cancer, melanoma, metastatic triple-negative breast cancer, relapsed or refractory peripheral T-cell lymphomaadult T-cell leukemia/lymphoma, extranodal NK-/T-cell lymphoma, nasal type, enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like t-cell lymphoma, primary cutaneous anaplastic large cell lymphoma, primary cutaneous T-cell lymphoma, primary cutaneous CD8+ T-cell lymphoma, transformed mycosis fungoides, primary cutaneous CD4+ small/medium T-cell lymphoproliferative disorder, angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, nodal peripheral T-cell lymphoma with TFH phenotype, ALK- and ALK+ anaplastic large-cell lymphoma. It was under development for the treatment of HPV associated nasopharyngeal cancer, diffuse large B-cell lymphoma, cervical cancer and liposarcoma, cutaneous T-cell lymphoma in the EU, metastatic renal cell carcinoma (RCC), relapsed or refractory multiple myeloma, HIV-1 infections, androgen independent metastatic prostate cancer and non-small cell lung cancer.

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, immunology, cardiovascular, and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, medical professionals, hospitals 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 Princeton, New Jersey, the US.

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

This content was updated on 20 May 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.