BRUKINSA - A Powerful Choice in R/R mcl

A BTK INHIBITOR THAT
CONTINUES TO DELIVER
DEEP AND SUSTAINED
RESPONSES IN R/R MCL1,2

BRUKINSA® (zanubrutinib) is indicated for the treatment 
of adult patients with mantle cell lymphoma (MCL) 
who have received at least one prior therapy.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

NCCN
Category 2A
Preferred

Zanubrutinib (BRUKINSA®) is included as a Category 2A preferred treatment option for second-line and subsequent therapy for MCL in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)3

POWERFUL, CONSISTENT RESPONSES

Initial analysis (18 months)1,4

84% of patients responded to BRUKINSA across both studies.1

Study 206
| PET-BASED
(N=86)
84
%
ORR
59
%
CR
Study 003 (MCL)
| CT-BASED
(N=32)
84
%
ORR
22
%
CR

Median follow-up time was 18.4 months for Study 206 and 18.8 months for Study 003.4



Long-Term analysis (35 months)5

84% of patients responded to BRUKINSA
in the long-term analysis.5

Study 206
| PET-BASED
(N=86)
84
%
ORR
78
%
CR

Median follow-up time was 35.3 months for Study 206.5

The efficacy of BRUKINSA was assessed in 2 clinical trials that included a total of 118 adult patients with MCL who received at least 1 prior therapy. Study BGB-3111-206 (Study 206): N=86, Phase 2, open-label, multicenter, single-arm trial; PET scans were required for response assessment. Study BGB-3111-AU-003 (Study 003): N=32, Phase 1/2, open-label, multicenter, single-arm trial; PET scans were not required for response assessment and the majority of patients were assessed mostly using CT scans.


CI=confidence interval; CR=complete response; CT=computed tomography; IRC=independent review committee; NCCN®=National Comprehensive Cancer Network®; ORR=overall response rate; PET=positron emission tomography; R/R=relapsed/refractory.

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BTK inhibition
 
Brukinsa Difference
Established
Safety Profile
Safety
Flexible
Dosing
Dosing