BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Approval for Chronic Lymphocytic Leukemia
- The approval was based on the results from the P-III studies (ALPINE) in 652 patients & (SEQUOIA) trial in 740 patients evaluating Brukinsa. The results showed superior efficacy & favorable safety profile
- In the (SEQUOIA) trial, the results showed a PFS benefit over bendamustine + rituximab with a median follow-up of 26.2mos. In the (ALPINE) trial, superior ORR over ibrutinib, ORR (80.4% vs 72.9%) while the overall safety profile in both trials was consistent with prior studies
- In the pre-defined final PFS analysis of the (ALPINE) study, superior PFS with a median follow-up of 29.6mos., favorable cardiac safety profile with lower rates of AF/flutter (5.2% vs 13.3%) & zero deaths due to cardiac disorders (0% vs 1.9%)
Ref: Businesswire | Image: BeiGene
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