BRUKINSA monotherapy is approved by HSE for CLL in adults who:3
- Are TN and have del(17p) and/or TP53-mutated disease
- 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 CLL1,4–9
Select one of the two options below:
- Primary endpoint: IRC-assessed PFS (N=479)4
- 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<0.00011,4
Over 75% of BRUKINSA patients without del(17p) were free of disease progression at 5 years9
Extended follow-up: PFS in patients without del(17p)9
Investigator-assessed; median follow-up: 61.2 months9
HR=0.29
(95% CI: 0.21, 0.40); p<0.0001
Adapted from Shadman, et al 2025.9
Similar PFS in mutated vs unmutated IGHV
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 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 features9,10
Long-term follow-up: PFS in patients with del(17p)10
Investigator-assessed; median follow-up: 65.8 months10
Adapted from Tam C, et al. 2025.10
Patients without del(17p)
Adapted from Shadman M, et al. 2025.9
Patients with del(17p)
Adapted from Tam C, et al. 2025.10
In patients with del(17p), ORR was consistent,
regardless of mutation or risk status13
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
