BeiGene’s Brukin­sa bags fifth FDA ap­proval, like­ly po­si­tion­ing it for con­tin­ued sales growth

BeiGene’s Brukin­sa has clinched a fifth US green light in B-cell ma­lig­nan­cies — this time for fol­lic­u­lar lym­phoma (FL) — fur­ther ex­pand­ing its reach in the BTK in­hibitor mar­ket.

The drug won an FDA ac­cel­er­at­ed ap­proval on Thurs­day in com­bi­na­tion with Roche’s Gazy­va for fol­lic­u­lar lym­phoma pa­tients af­ter two or more lines of pri­or ther­a­py based on da­ta from the Phase II ROSE­WOOD tri­al.

In ROSE­WOOD, the Brukin­sa reg­i­men achieved a 69% over­all re­sponse rate ver­sus 45.8% for Gazy­va at a me­di­an fol­low-up of 20 months (p=0.0012). The prod­uct’s con­tin­ued ap­proval in FL is con­tin­gent on re­sults from the on­go­ing con­fir­ma­to­ry MA­HOGANY study.

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