Wednesday, May 14, 2025

NICE Recommends BeiGene’s Brukinsa as Chronic Lymphocytic Leukemia Treatment in Final Draft Guidance

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The National Institute for Health and Care Excellence (NICE) has issued its final draft guidance (FDG) endorsing Brukinsa as a recommended treatment for eligible adults with chronic lymphocytic leukemia (CLL). This recommendation applies to patients with untreated CLL, including those with a 17p deletion or TP53 mutation.

Brukinsa is also recommended for adults with untreated CLL who do not have a 17p deletion or TP53 mutation, provided that the traditional treatment options of fludarabine-cyclophosphamide-rituximab (FCR) or bendamustine plus rituximab (BR) are unsuitable. Additionally, NICE recommends Brukinsa for individuals with relapsed or refractory CLL.

Dr. Robert Mulrooney, the General Manager of BeiGene UK and Ireland, expressed his satisfaction with NICE’s decision, emphasizing the company’s commitment to making innovative cancer medicines accessible and affordable for UK patients. BeiGene, although relatively new to the UK market, has been making significant strides in the field of cancer treatment. Brukinsa’s previous approval by NICE in July 2022 as a cost-effective treatment for patients with Waldenstrom’s macroglobulinemia was a testament to BeiGene’s dedication to improving cancer care.

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Brukinsa, developed by BeiGene scientists, is a small molecule inhibitor targeting Bruton’s tyrosine kinase (BTK). It is currently undergoing extensive clinical evaluation worldwide, both as a monotherapy and in combination with other therapies, to address various B-cell malignancies.

The therapy’s design prioritizes continuous and effective inhibition of the BTK protein. This is achieved through optimizing factors like bioavailability, half-life, and selectivity, as the BTK protein is consistently synthesized.

NICE’s final draft guidance recommending Brukinsa as a treatment for CLL underscores the therapy’s potential to make a significant impact in the field of cancer treatment. BeiGene’s commitment to innovation and patient access to groundbreaking treatments is evident in its rapid establishment as a key player in the UK market.


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