BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Approval for Chronic Lymphocytic Leukemia
Shots:
- 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
Related News:- BeiGene Presents P-III Trial (ALPINE) Results of Brukinsa (zanubrutinib) for Chronic Lymphocytic Leukemia at ASH 2022
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.