NICE has released the final draft guidance (FDG) that suggests Brukinsa as a recommended treatment for eligible adults with untreated CLL if there is a 17p deletion or TP53 mutation.
It is also recommended for adults with untreated CLL without a 17p deletion or TP53 mutation, and fludarabine-cyclophosphamide-rituximab (FCR) or bendamustine plus rituximab (BR) is unsuitable, as well as relapsed or refractory CLL.
BeiGene UK and Ireland general manager Dr Robert Mulrooney said: “This follows the previous approval of Brukinsa by NICE in July 2022 as the only cost-effective treatment for patients with Waldenstrom’s macroglobulinemia.
“Although we are a relatively new player in the UK market, we are rapidly establishing ourselves as a company that can make innovative cancer medicines accessible and affordable for UK patients.”
Brukinsa, discovered by BeiGene scientists, is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK).
It is currently undergoing worldwide clinical evaluation as a monotherapy and in combination with other therapies for a range of B-cell malignancies.
This therapy was designed to ensure continuous and effective inhibition of the BTK protein by optimising factors like bioavailability, half-life, and selectivity, as new BTK is consistently synthesized.
Brukinsa features differentiated pharmacokinetics compared to other approved BTK inhibitors.
The therapy has shown its effectiveness in inhibiting the growth of malignant B cells in various disease-relevant tissues.