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.

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