FDA grants fifth approval for BeiGene’s Brukinsa
The US Food and Drug Administration granted accelerated approval for Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
This becomes the fifth US approval for Sino-American firm BeiGene's (Nasdaq: BGNE) drug. The company noted that Brukinsa now has the broadest label of all drugs in the class.
Global sales of Brukinsa were $413.0 million and $1.3 billion for the fourth quarter and full year 2023, respectively, compared to $176.1 million and $564.7 million in the prior-year.
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