Blinatumomab is under clinical development by Amgen and currently in Phase II for Chronic Lymphocytic Leukemia (CLL). According to GlobalData, Phase II drugs for Chronic Lymphocytic Leukemia (CLL) have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Blinatumomab’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.
Blinatumomab overview
Blinatumomab (Blincyto) is a monoclonal antibody acts as antineoplastic agent. It is formulated as Lyophilized powder for solution for intravenous, intravenous drip route of administration. Blincyto is indicated for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL), for the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Blincyto is also indicated for the treatment of patients with Philadelphia chromosome-negative CD19 positive B-precursor acute lymphoblastic leukemia (ALL) in first or second hematologic complete remission with minimal residual disease (MRD)greater than or equal to 0.1%. Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. Blincyto (blinatumomab) is indicated for the treatment of pediatric patients with relapsed or refractory (R/R) CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).
Blinatumomab is under development for the treatment of relapsed or refractory precursor B-cell lymphoblastic leukemia in adults and children, newly diagnosed B-lymphoblastic leukemia and localized B-lymphoblastic lymphoma, B- precursor acute lymphoblastic leukemia, relapsed/refractory acute lymphoblastic leukemia (ALL), indolent B-cell non-Hodgkin's lymphoma, follicular lymphoma, nodal marginal zone B-Cell lymphoma, extranodal marginal zone B-Cell lymphoma and splenic marginal zone B-Cell lymphoma, marginal zone lymphoma. It is a bi-specific monoclonal antibody being developed based on BiTE Antibody technology. It was also under development for indolent B-cell lymphoma, B-cell chronic lymphocytic leukemia (CLL), KMT2A-rearranged acute lymphoblastic leukemia, hairy cell leukemia, mantle cell lymphoma, and small lymphocytic lymphoma.
It was also under development for primary mediastinal B-cell lymphoma, waldenstrom macroglobulinemia (lymphoplasmacytic lymphoma), diffuse large B-cell lymphoma
Amgen overview
Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in six focused disease areas including cardiovascular diseases, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to unravel the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels such as print, television and online media. Amgen is headquartered in Thousand Oaks, California, the US.
For a complete picture of Blinatumomab’s drug-specific PTSR and LoA scores, buy the report here.
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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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.
