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Zanubrutinib receives FDA approval for CLL and SLL

Jan 24, 2023
Learning objective: After reading this article, learners will be able to cite a new clinical development in chronic lymphocytic leukemia.

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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.

  • In the SEQUOIA trial, zanubrutinib showed a significant progression-free survival benefit versus bendamustine + rituximab
  • In the ALPINE trial, zanubrutinib demonstrated a superior overall response rate compared with ibrutinib in R/R patients
  • The overall safety profile of zanubrutinib therapy was consistent with previous studies in both trials

  1.  BRUKINSA® Approved in the U.S. for chronic lymphocytic leukemia. Published Jan 19, 2023. Accessed Jan 20, 2023.

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