BeiGene’s Receive EMA’s CHMP Positive Opinion for Brukinsa (zanubrutinib) to Treat Marginal Zone Lymphoma
Shots:
- The EMA’s CHMP has adopted the positive opinion recommending the approval of Brukinsa for MZL in adult patients who have received 1 prior anti-CD20-based therapy
- The recommendation was based on the P-II (MAGNOLIA) trial evaluating Brukinsa which showed ORR (68%), CR (26%) & PR (42%), and the median time to response was 2.8mos., ORRs for MZL subtypes extranodal/nodal/splenic/unknown were 64%/76%/67%/50%, respectively
- The therapy had a favorable & tolerability profile, the cardiac safety profile was consistent with prior studies with low rates of atrial fibrillation (3%) & atrial flutter (0.4%), was well-tolerated & low rates of discontinuation due to AEs (6%). The EC’s decision will be valid in all 27 member states of the EU, Iceland & Norway
Ref: Businesswire Image: BeiGene
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