BeiGene’s Brukinsa (zanubrutinib) Receives EC’s Approval for the Treatment Chronic Lymphocytic Leukemia
Shots:
- The EC has approved Brukinsa in adult patients with TN or r/r CLL
- The approval was based on the P-III (SEQUOIA) and (ALPINE) trial evaluating zanubrutinib (BTK inhibitor) vs bendamustine + rituximab or ibrutinib in 740 & 652 which showed superior efficacy in both trials & superiority to chemoimmunotherapy, ORR (80.4% vs 72.9%), and patients had a sustained response @1yr. with rates of 90% vs 78%, favorable safety profile incl. lower rates of AF/flutter
- The therapy has been approved in the EU for WM in adult patients who have received 1 prior therapy or as a 1L treatment for patients unsuitable for chemoimmunotherapy & for MZL who have received 1 prior anti-CD20-based therapy
Ref: Businesswire | Image: BeiGene
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