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Zanubrutinib receives EC approval for the treatment of adult patients with CLL
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.
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