Scientific Comments

Why did FDA grant Zanubrutinib breakthrough designation for mantle cell lymphoma?

  • ZHANG Hongtao
  • Pathology and Laboratory Medicine, Perelman School of Medicine, Philadelphia 19104, USA

Received date: 2019-01-28

  Revised date: 2019-02-05

  Online published: 2019-06-20


The U.S. Food and Drug Administration (FDA) has granted the investigational BTK inhibitor Zanubrutinib (BGB-3111) a breakthrough therapy designation for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received at least 1 prior therapy, on Jan. 15th 2019. This paper introduced the definition of the breakthrough therapy designation, the breakthrough achievements of Zanubrutinib, the significance of this event to Chinese pharmaceutical R&D enterprises.

Cite this article

ZHANG Hongtao . Why did FDA grant Zanubrutinib breakthrough designation for mantle cell lymphoma?[J]. Science & Technology Review, 2019 , 37(11) : 6 -8 . DOI: 10.3981/j.issn.1000-7857.2019.11.001


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