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NICE recommends BRUKINSA as an option for treating adult patients with CLL that is:1

  • Untreated and there is a 17p deletion or TP53 mutation, or
  • Untreated, there is no 17p deletion or TP53 mutation, and fludarabine plus cyclophosphamide and rituximab, or bendamustine plus rituximab is unsuitable, or
  • Relapsed or refractory

It is recommended only if the company provides it according to the commercial arrangement1

BRUKINSA monotherapy is accepted by SMC as an option for treating adults with CLL:2

  • In whom chemo-immunotherapy is unsuitable.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower2

BRUKINSA is the only BTK inhibitor to demonstrate superior efficacy both vs CIT in TN CLL and vs ibrutinib in R/R CLL3–7

Select one of the two options below:

Treatment-naïve CLL Relapsed or refractory CLL
  • Primary endpoint: IRC-assessed PFS (N=479)
  • At a median follow-up of 25.0 months, BRUKINSA demonstrated superior PFS vs BR; HR=0.42 (95% CI: 0.28, 0.63); p<0.0001

PFS benefit was maintained with extended follow-up9

Investigator-assessed PFS in patients without del(17p) Median follow-up 61.2 months

HR=0.29

(95% CI: 0.21, 0.40); p<0.0001

Adapted from Shadman, et al 2025.9

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PFS vs BR by IGHV status in TN CLL without del(17p)9

Median follow-up 61.2 months

Unmutated IGHV:

HR=0.21

n=248 (95% CI: 0.14, 0.33)

Mutated IGHV:

HR=0.40

n=218 (95% CI: 0.23, 0.69)

PFS in TN CLL with del(17p)10

Investigator-assessed PFS; median follow-up 47.9 months

Adapted from Munir, et al. 2023.10

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Patients reported better physical functioning and reduced fatigue by Week 24 with BRUKINSA vs BR

(N=479)

GHS/QoL: p=0.0169
Physical functioning: p=0.0121

Fewer GI symptoms were reported with BRUKINSA vs BR at Week 24

(N=479)

Diarrhoea: p=0.0012
Nausea/vomiting: p=0.0015
Patients without del(17p):
20.0%

Median follow-up: 61.2 months; n=240

Patients with del(17p):
13.5%

Median follow-up: 47.9 months; n=111

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