Science & Technology Review
|
2019, 37(11): 6-8
• Scientific Comments •
Why did FDA grant Zanubrutinib breakthrough designation for mantle cell lymphoma?
Full
ZHANG Hongtao
Affiliations
Published: 2019-06-13
doi: 10.3981/j.issn.1000-7857.2019.11.001
Outline
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.
breakthrough designation
/
anticancer drugs
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Zanubrutinib
张洪涛.
中国第一个获得美国FDA“突破性疗法”认证的抗癌新药,到底好在哪?.
科技导报,
2019
, 37
(11)
: 6
-8
.
DOI: 10.3981/j.issn.1000-7857.2019.11.001
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
Year 2019 volume 37 Issue 11
PDF
597
158
Cite this Article
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Article Info
doi: 10.3981/j.issn.1000-7857.2019.11.001
- Receive Date:2019-01-28
- Online Date:2019-06-20
- Published:2019-06-13