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HSE recommends BRUKINSA as monotherapy for the treatment of adult patients with CLL:1

  • Who are treatment naive and have del(17p) and/or TP53-mutated disease
  • Who have R/R disease following at least one line of prior therapy

BRUKINSA is the only BTK inhibitor to demonstrate superior efficacy both vs CIT in TN CLL and vs ibrutinib in R/R CLL2–6

Select one of the two options below:

  • 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-up8

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 2025.8

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PFS vs BR by IGHV status in TN CLL without del(17p)8

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)9

Investigator-assessed PFS; median follow-up 47.9 months

Adapted from Munir, et al. 2023.9

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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=110

Select an indication to learn more about BRUKINSA: