Zanubrutinib by BeiGene for Secondary CNS Lymphoma: Likelihood of Approval

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 is specialized in the development and commercialization of immuno-oncology medicines to treat cancers. The company offers BRUKINSA, a BTK (Bruton’s tyrosine kinase) inhibitor against mantle cell lymphoma (MCL). BeiGene also provides Zanubrutinib (BGB-3111), a small molecule inhibitor of BTK to treat B cell malignancies; 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, Switzerland, and Italy. BeiGene is headquartered in Beijing, China.

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

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.