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Thursday, November 14, 2019

FDA OKs BeiGene’s zanubrutinib for mantle cell lymphoma

The FDA grants accelerated approval to BeiGene’s (BGNE -0.6%) BTK inhibitor zanubrutinib, branded as Brukinsa, for the treatment of mantle cell lymphoma, an aggressive type of non-Hodgkin lymphoma, its first approved drug in the U.S.
Zanubrutinib had Breakthrough Therapy and Orphan Drug status for the indication.

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