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The FDAs decision was supported by data from the Phase II ROSEWOOD trial, in which the BrukinsaGazyva combo led to a 69% overall response rate (ORR) compared to 46% ORR in patients treated with Gazyva alone, according to BeiGene

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In the 2025 human IV infusion pilot, two adults receiving 10-20 mg doses showed no measurable changes in cardiac, hepatic, renal, thyroid, or glucose markers