BeiGene notched its fifth US approval for Brukinsa (zanubrutinib) on Thursday when it became the first BTK inhibitor cleared to treat follicular lymphoma (FL). According to the drugmaker, Brukinsa now has the broadest label of all drugs in the class.
The FDA granted accelerated approval to Brukinsa in combination with Roche’s anti-CD20 antibody Gazyva (obinutuzumab) to treat relapsed or refractory FL patients after they’ve received two or more lines of systemic therapy. The combination received EU approval in November.
The latest approval was based on the 217-patient Phase II ROSEWOOD study, in which Brukinsa plus Gazyva led to an overall response rate of 69% versus 46% for Gazyva alone. The combination also saw an 18-month duration of response of 69%.
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