The European Commission (EC) has approved the Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia (CLL).
The EC approval is based on positive results from two phase III clinical trials: the SEQUOIA trial, which compared zanubrutinib with bendamustine plus rituximab in treatment-naïve CLL, and the ALPINE study, which compared zanubrutinib with ibrutinib in patients with relapsed or refractory CLL.
In these trials, zanubrutinib demonstrated superior efficacy versus either bendamustine plus rituximab or ibrutinib in first-line or relapsed/refractory CLL, respectively.
Zanubrutinib is currently approved in the European Union for the treatment of adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy or as the first-line treatment for patients unsuitable for chemoimmunotherapy. In September 2022, the Committee for Medicinal Products for Human Use of the EMA issued a positive opinion recommending approval of zanubrutinib for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy.
Source: Business Wire, November 2022