Zanubrutinib is under clinical development by BeiGene and currently in Phase III for Relapsed Chronic Lymphocytic Leukemia (CLL). According to GlobalData, Phase III drugs for Relapsed Chronic Lymphocytic Leukemia (CLL) have a 64% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Zanubrutinib’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.

Zanubrutinib overview

Zanubrutinib (Brukinsa) acts as an antineoplastic agent. It is formulated as hard gelatin capsules for oral route of administration. Brukinsa is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and the treatment of adult patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) who have received at least one prior therapy. Brukinsa is indicated for the treatment of adult patients with Waldenstrom’s macroglobulinemia (WM), Brukinsa is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least a previous therapy. Brukinsa is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.

Zanubrutinib (BGB-3111) is under development for the treatment of B-cell lymphoid malignancies such as relapsed/refractory diffuse large B-cell lymphoma, follicular lymphoma, relapsed/refractory mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), relapsed/refractory primary and secondary central nervous system lymphomas, Immune Thrombocytopenic Purpura, primary membranous nephropathy and lupus nephritis. The drug candidate is administered through oral route and acts by targeting brutons tyrosine kinase (BTK).

It was under development for the treatment of severe acute respiratory syndrome due to Coronavirus disease 2019 (COVID-19), pulmonary distress.

BeiGene overview

BeiGene is a biotechnology company. It specializes in the development and commercialization of immuno-oncology medicines to treat cancers. The company offers Zanubrutinib, a small molecule inhibitor to treat various blood cancers and Sonrotoclax, a small molecule Bcl-2 inhibitor for treating chronic lymphocytic leukemia. BeiGene also provides Tislelizumab (BGB-A317), a monoclonal antibody targeting solid tumors and hematologic cancer; and Pamiparib (BGB-290) against solid tumor malignancies. The company has operations in the US, Australia, Germany, Spain, Canada, Switzerland and Italy. BeiGene is headquartered in the Cayman Islands.

For a complete picture of Zanubrutinib’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.