BeiGene has secured the approval of the US Food and Drug Administration (FDA) for the company’s Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Brukinsa FDA approval is backed by the findings of two global phase 3 clinical trials wherein Brukinsa showed superior efficacy and a favorable safety profile in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Mehrdad Mobasher — BeiGene Hematology Chief Medical Officer, commenting on Brukinsa FDA approval, said: “With four US approvals in just over three years and demonstrated superiority versus ibrutinib in the final progression-free survival (PFS) analysis of the ALPINE trial, we believe BRUKINSA is well-positioned to become the BTKi of choice across multiple indications.”

Brukinsa with a median follow-up of 26.2 months in the SEQUOIA clinical trial, showed a significant progression-free survival (PFS) benefit compared to bendamustine plus rituximab in patients with treatment-naïve chronic lymphocytic leukemia or small lymphocytic lymphoma.

In the randomized, global ALPINE phase 3 clinical trial of around 650 patients, Brukinsa achieved a superior overall response rate against Imbruvica (ibrutinib) (ORR 80.4% vs 72.9%) in previously treated patients having relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The overall safety profile of BRUKINSA in the ALPINE and SEQUOIA trials was consistent with prior studies, according to BeiGene.

Brukinsa, a Bruton’s tyrosine kinase inhibitor (BTKi), is also indicated for the treatment of adult patients with Waldenström’s macroglobulinemia, mantle cell lymphoma (MCL) who have received at least one prior therapy, relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.

The continued approval for mantle cell lymphoma and marginal zone lymphoma indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

  BeiGene, Brukinsa, chronic lymphocytic leukemia, Hematology, ibrutinib, IMBRUVICA, Leukemia, lymphocytic lymphoma, Lymphoma, mantle cell lymphoma, Mehrdad Mobasher, rituximab, small lymphocytic lymphoma, US FDA, US Food and Drug Administration, zanubrutinib