Relapsed or refractory CLL - Brukinsa®▼ (zanubrutinib)

NICE recommends BRUKINSA as an option for treating adult patients with CLL that is:¹

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 arrangement¹

BRUKINSA monotherapy is accepted by SMC as an option for treating adults with CLL:²

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 lower²

BRUKINSA is the only BTK inhibitor to demonstrate superior efficacy both vs CIT in TN CLL and vs ibrutinib in R/R CLL^3–7

Select one of the two options below:

Treatment-naïve CLL Relapsed or refractory CLL

Median follow-up 29.6 months

Primary endpoint: IRC-assessed ORR⁵

79.5%

BRUKINSA

71.1%

ibrutinib

superiority two-sided p=0.0133

Key secondary endpoint: PFS vs ibrutinib⁵

HR=0.65

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

Benefit was maintained with extended follow-up¹³

Overall median follow-up: 42.5 months

PFS vs ibrutinib

HR=0.68

(95% CI: 0.54, 0.84)

Investigator-assessed ORR at 42.5 months

Adapted from Brown, et al. 2024.¹³

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

Overall median follow-up: 42.5 months

HR=0.51

(95% CI: 0.33, 0.78)

Adapted from Brown, et al. 2024.¹³

Overall median follow-up: 42.5 months

Atrial fibrillation

7.1%

BRUKINSA
(n=23/324)

17.0%

ibrutinib
(n=55/324)

Treatment discontinuation due to cardiac AEs

0.9%

BRUKINSA
(n=3/324)

4.9%

ibrutinib
(n=16/324)

Treatment discontinuation due to AEs

Overall median follow-up: 42.5 months

20.1%

BRUKINSA
(n=65/324)

27.5%

ibrutinib
(n=89/324)