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Zanubrutinib receives EC approval for the treatment of adult patients with CLL
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On November 17, 2022, it was announced that the European Commission (EC) had granted approval to zanubrutinib, a Bruton’s tyrosine kinase inhibitor, for the treatment of adult patients with previously untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL).
The approval is based on key data from two clinical trials: SEQUOIA (NCT03336333), in patients with previously untreated CLL, and ALPINE (NCT03734016), in patients with R/R CLL. In both trials, zanubrutinib demonstrated favorable efficacy over either bendamustine + rituximab or ibrutinib in previously untreated or R/R CLL, with an acceptable safety profile consistent with previous studies.
- Business Wire. BeiGene receives European Commission approval for BRUKINSA® (zanubrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL). https://www.businesswire.com/news/home/20221117005394/en/BeiGene-Receives-European-Commission-Approval-for-BRUKINSA%C2%AE-zanubrutinib-for-the-Treatment-of-Adults-with-Chronic-Lymphocytic-Leukemia-CLL. Published Nov 17, 2022. Accessed Nov 18, 2022.
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