BeiGene Announces New Indication for Zanubrutinib: First-Line Treatment of Waldenström's Macroglobulinemia

On January 20, BeiGene issued an announcement announcing that the marketing application for the new indication of zanubrutinib was accepted
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Zanubrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK) developed by BeiGene and is currently undergoing extensive clinical trials globally as a single agent and in combination with other therapies Treatment of a variety of B cell malignancies
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The marketing application of Baiyueze® for the treatment of adult patients with Waldenström's macroglobulinemia is based on the results of the ASPEN trial
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Complete remission (CR) and very good partial response in the overall intention-to-treat population in the Baiyueze® treatment group as assessed by an independent review committee according to the 6th International Symposium on Waldenström's Macroglobulinemia Revised Response Criteria (Treon2015) The response (VGPR) rate was 28% (95% CI: 20, 38) compared with 19% (95% CI: 12, 28) in the ibrutinib arm
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Although the difference between the two groups did not reach statistical significance (p value = 0.
09), the Baiyueze® treatment group showed higher VGPR rate data, and the quality of remission showed a trend of improvement
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In the ASPEN trial, Baiyueze® achieved superior safety data compared to ibrutinib, with lower rates of specific adverse events, including atrial fibrillation/flutter (2% for Baiyueze® 15% versus ibrutinib) and major bleeding (6% for Baiyueze® versus 9% for ibrutinib)
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