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NICE recommends BRUKINSA as an option for treating adult patients with CLL that is:3

  • 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 arrangement3

BRUKINSA monotherapy is accepted by SMC as an option for treating adults with CLL:4

  • 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 lower4

BRUKINSA is the only BTK inhibitor to demonstrate superior efficacy both vs CIT in TN CLL and vs ibrutinib in R/R CLL1,5–10

Select one of the two options below:

Treatment-naïve CLL Relapsed or refractory CLL
  • Primary endpoint: IRC-assessed PFS (N=479)5
  • 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<0.00011,5

Over 75% of BRUKINSA patients without del(17p) were free of disease progression at 5 years10

Extended follow-up: PFS in patients without del(17p)10

Investigator-assessed; median follow-up: 61.2 months10

HR=0.29

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

Adapted from Shadman, et al 2025.10

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Similar PFS in mutated vs unmutated IGHVin TN CLL without del(17p)10

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 mutated vs unmutated IGHV: HR=1.35 (95% CI: 0.76, 2.40)

Patients with del(17p) achieved progression-free survival comparable to those without high-risk features10,11

Long-term follow-up: PFS in patients with del(17p)11

Investigator-assessed; median follow-up: 65.8 months11

Adapted from Tam, et al. 2025.11

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Patients without del(17p)

Adapted from Shadman M, et al. 2025.10

Patients with del(17p)

Adapted from Tam C, et al. 2025.11

In patients with del(17p), ORR was consistent, regardless of mutation or risk status14

Patient-reported outcomes were better with BRUKINSA vs BR at Week 24

(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%

Median follow-up: 61.2 months; n=240

Patients with del(17p):
17%

Median follow-up: 65.8 months; n=111

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