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On January 19, 2023, it was announced that the U.S. Food and Drug Administration (FDA) had granted approval to zanubrutinib, a Bruton’s tyrosine kinase inhibitor, for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1
The approval is based on key data obtained from the SEQUOIA trial (NCT03336333), which compared zanubrutinib with bendamustine + rituximab in patients with previously untreated CLL or SLL, and the ALPINE trial (NCT03734016), which compared zanubrutinib with ibrutinib in patients with relapsed or refractory (R/R) CLL or SLL.
Both trials demonstrated improved efficacy and an acceptable safety profile for zanubrutinib in CLL/SLL.
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