Brukinsa bags broadest BTK label after FDA clears follicular lymphoma combo

2024-03-07

临床结果上市批准临床3期临床2期加速审批

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.

Thursday’s greenlight comes a little over a year after its most recent US approval, which was for relapsed/refractory chronic lymphocytic leukaemia. Brukinsa is also approved in both the US and Europe to treat mantle cell lymphoma, Waldenström's macroglobulinaemia and marginal zone lymphoma. For more, see ViewPoints: Safety makes Brukinsa first choice in chronic lymphocytic leukaemia.

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%.

Full approval in FL may depend on the results of the confirmatory Phase III MAHOGANY trial, which is comparing the Brukinsa/Gazyva combo against Revlimid (lenalidomide) plus Rituxan (rituximab).

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