By Fineline Cube China-based biotech BeiGene Inc. (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced receiving marketing approval from the European Committee (EC) for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The drug is now approved in the EU for the treatment of relapsed/refractory (R/R) marginal zone lymphoma (MZL) in patients who have previously received at least one anti-CD20 therapy. Notably, the drug’s market protection period has been extended by one year due to the significant clinical benefits demonstrated in the data filed for this indication compared to existing therapies.
Clinical Data and Market Context
The EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the additional indication approval for Brukinsa in MZL patients who have received at least one prior anti-CD20-based therapy in September this year. This recommendation was based on the positive results of the MAGNOLIA study. In the open, multi-center, single-arm Phase II study, the overall response rate (ORR) was 68% (95% CI: 55.6, 79.1), with 26% achieving a complete response (CR) and 42% achieving a partial response (PR). Subjects had a median time to response of 2.8 months (range: 1.7-11.1 months), and the drug demonstrated a safe and tolerable profile, consistent with previous findings.
Drug Profile and Development
Brukinsa was developed in-house by BeiGene and 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. Designed to deliver targeted and sustained inhibition of the BTK protein, Brukinsa optimizes bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other licensed BTK inhibitors, Brukinsa has been shown to inhibit the proliferation of malignant B cells in disease-relevant tissues. The drug has previously been approved to treat Waldenström’s macroglobulinemia (WM) in Europe, where CHMP issued a positive opinion recommending approval of Brukinsa for the treatment of adult patients with chronic lymphocytic leukemia (CLL) last month. Additionally, multiple countries reimburse the drug for use in WM.
Future Development
The approval from the EC underscores Brukinsa’s potential to address significant unmet needs in the treatment of marginal zone lymphoma. BeiGene remains committed to advancing innovative therapies for patients with B-cell malignancies, with ongoing clinical studies aimed at further exploring the drug’s efficacy and safety.-Fineline Info & Tech