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The US FDA Approves BeiGene’s Label Update for Brukinsa to Include Chronic Lymphocytic Leukemia

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The US FDA Approves BeiGene’s Label Update for Brukinsa to Include Chronic Lymphocytic Leukemia

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  • The label expansion was based on the results from the P-III (ALPINE) clinical trial evaluating the safety & efficacy of Brukinsa vs Imbruvica in patients previously treated with r/r chronic lymphocytic leukemia (CLL)
  • With a median follow-up of 31mos. the study depicted a superior PFS & demonstrated a favorable cardiac safety profile with significantly lower rates of atrial fibrillation/flutter (5.2% vs 13.3%) & lower deaths (0 vs 6) in patients receiving Brukinsa vs Imbruvica
  • These results were presented at the ASH 2023 & were presented in The New England Journal of Medicine. Brukinsa is a small molecule inhibitor of BTK designed to deliver complete and sustained inhibition of the BTK protein

Ref: BeiGene Image: BeiGene

Related News:- BeiGene’s Brukinsa with Obinutuzumab Receives the EC’s Approval for the Treatment of Follicular Lymphoma

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Kritika Jha

Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.

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