Zanubrutinib: First Approval

Drugs. 2020 Jan;80(1):91-97. doi: 10.1007/s40265-019-01252-4.

Abstract

Zanubrutinib (Brukinsa®), an orally-administered Bruton tyrosine kinase (BTK) inhibitor, is being developed by BeiGene for the treatment of B-cell malignancies. Zanubrutinib received accelerated approval in the USA on 14 November 2019 for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, based on overall response rate (ORR) seen in phase II and I/II clinical trials. This article summarizes the milestones in the development of zanubrutinib leading to this first approval for the treatment of MCL.

Publication types

  • Review

MeSH terms

  • Administration, Oral
  • Adult
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / pharmacology
  • Drug Approval
  • Humans
  • Lymphoma, B-Cell / drug therapy
  • Lymphoma, B-Cell / pathology
  • Lymphoma, Mantle-Cell / drug therapy*
  • Lymphoma, Mantle-Cell / pathology
  • Piperidines / administration & dosage*
  • Piperidines / pharmacology
  • Protein Kinase Inhibitors / administration & dosage*
  • Protein Kinase Inhibitors / pharmacology
  • Pyrazoles / administration & dosage*
  • Pyrazoles / pharmacology
  • Pyrimidines / administration & dosage*
  • Pyrimidines / pharmacology

Substances

  • Antineoplastic Agents
  • Piperidines
  • Protein Kinase Inhibitors
  • Pyrazoles
  • Pyrimidines
  • zanubrutinib