Brexucabtagene autoleucel is under clinical development by Gilead Sciences and currently in Phase II for Primary Mediastinal B-Cell Lymphoma. According to GlobalData, Phase II drugs for Primary Mediastinal B-Cell Lymphoma have an 82% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Brexucabtagene autoleucel’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.
Brexucabtagene autoleucel overview
Brexucabtagene Autoleucel (Tecartus) is a CD19-directed genetically modified autologous T cell immunotherapy comprised of patient’s own T cells which are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single-chain variable fragment (scFv) linked to CD28 and CD3-zeta co-stimulatory domains. It is formulated as suspension for intravenous route of administration. Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). Tecartus is indicated for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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Brexucabtagene autoleucel (KTEX-19) is under development for the treatment of solid tumor, relapsed or refractory B-cell acute lymphoblastic leukemia, relapsed or refractory acute lymphocytic leukemia, mantle cell lymphoma, recurrent chronic lymphocytic leukemia, acute lymphocytic leukemia, burkitt lymphoma, refractory acute myeloid leukemia, diffuse large b-cell lymphoma, refractory chronic lymphocytic leukemia, relapsed chronic lymphocytic leukemia, hairy cell leukemia, waldenstrom macroglobulinemia (lymphoplasmacytic lymphoma), follicular lymphoma and primary mediastinal large B-cell lymphoma (PMBCL). The therapeutic candidate is an autologous T-cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor. It is administered through intravenous route.
Gilead Sciences overview
Gilead Sciences (Gilead) is a research-based biopharmaceutical company. It is engaged in the discovery, development and commercialization of medicines for the treatment of cardiovascular, hematological and respiratory diseases, inflammation, liver diseases, cancer, and human immunodeficiency virus (HIV) infection. The company sells its products through subsidiaries and distributors in Europe, the Americas, Asia-Pacific, the Middle East and Africa. It has manufacturing facilities in Edmonton, Alberta, Canada; Foster City, San Dimas, Oceanside, California; and Cork, Ireland among others. The company has partnerships with universities, medical research institutions and global pharmaceutical leaders to develop new drugs. Gilead is headquartered in Foster City, California, the US.
For a complete picture of Brexucabtagene autoleucel’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 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.
