China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval of Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL). This recommendation is based on two global head-to-head Phase III clinical trials that demonstrated Brukinsa’s superior efficacy.
Clinical Trial Results
The CHMP recommendation is supported by data from two global Phase III clinical trials: the ALPINE (NCT03734016) study, which compared Brukinsa to ibrutinib in patients with relapsed or refractory (R/R) CLL, and the SEQUOIA (NCT03336333) study, which compared Brukinsa to rituximab in patients with treatment-naive (TN) CLL. These studies enrolled patients from a total of 17 countries, including the United States, China, Australia, New Zealand, and multiple countries in Europe.
Brukinsa: Mechanism and Development
Brukinsa is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists. It is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. The drug was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, Brukinsa has been shown to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.
Regulatory and Market Access
Brukinsa has already been approved in the European Union (EU) for the treatment of Waldenström’s macroglobulinemia (WM) and was recently recommended for the treatment of marginal zone lymphoma (MZL). Additionally, it has been covered by reimbursement systems in multiple European countries for use in WM, highlighting its growing acceptance and availability in the region.
Future Outlook
The positive CHMP opinion for Brukinsa in CLL underscores BeiGene’s progress in advancing innovative treatments for B-cell malignancies. With a robust clinical program and multiple regulatory milestones achieved, BeiGene aims to further expand the therapeutic options for patients with CLL and other B-cell malignancies.-Fineline Info & Tech
