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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

Nearly three-quarters of patients without del(17p) remained progression free at 6 years11

Extended follow-up: PFS in patients without del(17p)11

Investigator-assessed; median follow-up: 72.8 months11

HR=0.28

(95% CI: 0.20, 0.38); p<0.0001

Adapted from Tam CS, et al. 2025.11

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BRUKINSA demonstrated sustained PFS benefit regardless of IGHV mutation status11

Long-term follow-up: Number of PFS events by IGHV mutational status in patients without del(17p)11

Median follow-up: 72.8 months

Unmutated IGHV:

36 (29%)

n=248

Mutated IGHV:

21 (19%)

n=218

No significant difference between mutated and unmutated IGHV subgroups treated with BRUKINSA: HR=1.49; p=0.1411

Patients with del(17p) achieved progression-free survival comparable to those without high-risk features11

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

Investigator-assessed; median follow-up: 76.7 months11

Estimated 72-month PFS in patients with del(17p) was 65% with mutated IGHV and 64% with unmutated IGHV11

Adapted from Tam CS, et al. 2025.11

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Patients without del(17p)

Adapted from Tam CS, et al. 2025.11

Patients with del(17p)

Adapted from Tam CS, et al. 2025.11

Responses with BRUKINSA deepened over time11,14

Patient-reported outcomes were better with BRUKINSA vs BR at Week 2415

(N=479)

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

Fewer GI symptoms were reported with BRUKINSA vs BR at Week 2415

(N=479)

Diarrhoea: p=0.0012
Nausea/vomiting: p=0.0015
Most patients were still taking BRUKINSA at ~6 years median follow-up11
Patients without del(17p):
59%

Median follow-up: 72.8 months; n=142/241

Patients with del(17p):
55%

Median follow-up: 76.7 months; n=61/110

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