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