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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:

Median follow-up 29.6 months

Primary endpoint: investigator-assessed ORR6

80%

BRUKINSA

VS

71%

ibrutinib

superiority two-sided p=0.0133

Key secondary endpoint: PFS vs ibrutinib6

HR=0.65

(95% CI: 0.49, 0.86); p=0.0024

Higher and deeper responses with superior PFS compared to ibrutinib in R/R CLL12

Investigator assessed; median follow-up: 42.5 months

PFS vs ibrutinib

HR=0.68

(95% CI: 0.54, 0.84)

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Long-term follow-up: 48-month ORR

Investigator-assessed; median follow-up 42.5 months

Adapted from Brown, et al. 2024.12

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PFS in patients with del(17p), TP53 mutation or both vs ibrutinib

Investigator assessed; median follow-up: 42.5 months

HR=0.51

(95% CI: 0.33, 0.78)

Adapted from Brown, et al. 2024.12

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Overall median follow-up: 42.5 months

Atrial fibrillation

7%

BRUKINSA
(n=23/324)

VS

17%

ibrutinib
(n=55/324)

Treatment discontinuation due to cardiac AEs

1%

BRUKINSA
(n=3/324)

VS

5%

ibrutinib
(n=16/324)

Treatment discontinuation due to AEs

Overall median follow-up: 42.5 months

20%

BRUKINSA
(n=65/324)

VS

28%

ibrutinib
(n=89/324)

Select an indication to learn more about BRUKINSA: