BeiGene's BRUKINSA Receives European Commission Approval for CLL Treatment

BRUKINSA, a Bruton’s Tyrosine Kinase (BTK) inhibitor developed by BeiGene, has been approved by the European Commission for the treatment of adult patients with treatment-naïve (TN) or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). This approval is based on positive outcomes from two Phase 3 clinical trials, SEQUOIA and ALPINE, where BRUKINSA demonstrated superior efficacy over existing treatments, including IMBRUVICA® (ibrutinib) and chemoimmunotherapy.

In the SEQUOIA trial, BRUKINSA showed significant benefits for patients with previously untreated CLL, while the ALPINE trial highlighted its advantages for those with R/R CLL. Notably, BRUKINSA achieved an overall response rate (ORR) of 80.4% compared to 72.9% for ibrutinib in R/R CLL patients, with a higher rate of sustained response at one year (90% vs. 78%). The safety profile of BRUKINSA was favorable, with lower rates of atrial fibrillation/flutter compared to ibrutinib.

Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene, emphasized the importance of this approval, stating, "This approval represents an important milestone for CLL patients and their physicians who now have a new chemotherapy-free treatment option." Prof. Clemens Wendtner from Munich Clinic also highlighted the clinical improvements BRUKINSA offers over first-generation BTK inhibitors, noting its effectiveness and tolerability.

BRUKINSA is currently approved in the EU for treating adult patients with Waldenström’s macroglobulinemia (WM) and marginal zone lymphoma (MZL) who have received at least one prior therapy. BeiGene has secured reimbursement for BRUKINSA in several European countries, with ongoing processes in additional EU countries.

Chronic Lymphocytic Leukemia (CLL) is a slow-growing, life-threatening cancer that affects adults, characterized by abnormal leukemic B lymphocytes. It is one of the most common types of leukemia, with an estimated incidence of 4.92 per 100,000 persons annually in Europe.

BRUKINSA's development reflects BeiGene's commitment to advancing innovative and affordable oncology medicines. With a broad clinical program involving over 4,700 subjects in 35 trials across more than 25 countries, BRUKINSA is now approved in 58 markets worldwide, including the United States, China, and the European Union.