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BeiGene's Brukin­sa wins CLL ap­proval af­ter top­ping Im­bru­vi­ca in head-to-head tri­al

The FDA greenlit BeiGene’s Brukinsa for use in chronic lymphocytic leukemia, an approval that should substantially expand the market for the drug in the US after it topped the current leading therapy in a trial.

The approval, which is for relapsed/refractory and first-line treatment for adults with CLL as well as small lymphocytic lymphoma, is the drug’s fourth US clearance. It comes after BeiGene showed the twice-daily oral drug beat the standard of care, AbbVie and Johnson & Johnson’s Imbruvica, in a head-to-head test.