Mantle Cell Lymphoma

NICE recommends BRUKINSA as an option for treating adult patients with R/R MCL who have had one line of treatment only.³

It is only recommended if the company provides it according to the commercial arrangement.³

SMC accepts BRUKINSA as an option for treating adults patients with R/R MCL who have received at least one prior therapy.⁴

This advice applies only in the context of an approved NHSScotland PAS arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/list price that is equivalent or lower.⁴

Use after ibrutinib The Cancer Drug Fund allows patients to transfer to BRUKINSA if they have suffered unacceptable toxicity on therapy with ibrutinib, without any evidence of disease progression.⁵

BRUKINSA achieved deep responses that translated into meaningful long-term survival in R/R MCL^6,7

Primary endpoint: IRC-assessed ORR

Median follow-up: 18.4 months

Adapted from Song, et al. 2020.⁶

Secondary endpoint: INV-assessed ORR

Median follow-up: 35.3 months

Adapted from Song, et al. 2022.⁷

Median follow-up: 35.3 months

ORR by subgroup

TP53 mutation

80%

(52–96)

CR 67% (38–88)

(n=15)

Blastoid histology

67%

(35–90)

CR 67% (35–90)

(n=12)

Ki67 >30%

71%

(53–85)

CR 62% (44–78)

(n=34)

Refractory disease

84%

(71–94)

CR 82% (68–92)

(n=45)

Adapted from Song, et al. 2022.⁷

Secondary endpoint: PFS

Median follow-up: 35.3 months

Adapted from Song, et al. 2022.⁷

Discontinuations due to AEs

(n=8/86)

Median duration of treatment (28-day cycles): 19.3 cycles

No dose reductions or discontinuations due to AEs during the extension period
No new safety signals were observed during extended follow-up
Most AEs occurred early in treatment

No patients experienced:⁷

Atrial fibrillation/flutter

Grade ≥3 cardiac AEs

Second primary malignancy

Tumour lysis syndrome

BRUKINSA achieved deep responses that translated into meaningful long-term survival in R/R MCL^6,7