BRUKINSA® Gains NICE's Positive Endorsement for Adult Chronic Lymphocytic Leukemia Patients in the United Kingdom

Saturday, October 21, 2023

BeiGene, a global biotechnology company listed on Nasdaq (BGNE), Hong Kong Stock Exchange (HKEX: 06160), and SSE (SSE: 688235), has made a significant announcement. The National Institute for Health and Care Excellence (NICE) in the United Kingdom (U.K.) has issued final draft guidance (FDG) endorsing the use of BRUKINSA® (zanubrutinib) for the treatment of specific adult patients. This endorsement covers:

  • Untreated chronic lymphocytic leukemia (CLL) in cases involving a 17p deletion or TP53 mutation, which are considered high-risk.
  • Untreated CLL in situations where traditional treatments such as fludarabine-cyclophosphamide-rituximab (FCR) or bendamustine plus rituximab (BR) are deemed unsuitable.
  • Relapsed or refractory CLL.

NICE's evaluation determined that in the aforementioned cases, zanubrutinib exhibits compelling cost-effectiveness compared to other BTK inhibitors. This recommendation is noteworthy, underscoring the potential of zanubrutinib in treating CLL patients while considering its efficacy and cost-effectiveness.

It's worth mentioning that BRUKINSA® now stands as the third BTK inhibitor (BTKi) for CLL to receive a NICE recommendation for routine commissioning. Developed by BeiGene scientists, BRUKINSA® is a small molecule inhibitor of Bruton's tyrosine kinase (BTK). It's currently undergoing extensive global clinical evaluation, both as a standalone treatment and in combination with other therapies for various B-cell malignancies. BRUKINSA® is specifically designed to provide comprehensive and sustained inhibition of the BTK protein, achieved through optimized bioavailability, half-life, and selectivity. Its effectiveness in inhibiting malignant B cell proliferation in diverse disease-relevant tissues sets it apart from other approved BTK inhibitors. This development opens up new possibilities for CLL patients, especially those who may not respond to initial treatments or face relapse.


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