BRUKINSA patients can call the myBeOne Support™ program to talk to a dedicated nurse: 1-833-234-4363
*Median PFS was not reached in either arm at the initial analysis.1,2
†Prespecified analysis assessed by IRC.2
‡Analyses are exploratory and descriptive in nature.
*Assessed by investigator.3
†Median follow-up at the long-term analysis: 61.2 months.3
‡The hazard ratio and 95% CI were assessed using a stratified (for all patients) or unstratified (for subgroup) Cox regression model with the BR arm as the reference arm.3
§Cytopenia: anemia (hemoglobin ≤110 g/L), thrombocytopenia (platelet count ≤100 x 109/L), or neutropenia (absolute neutrophil count ≤1.5 x 109/L).3
¶On the basis of monosomy 13q mutation results.3
Cohort 1: without del(17p)/TP53
secondary endpoint*
93% ORRwith BRUKINSA (n=241) at ~2 years
(95% CI: 89.0, 96.0) vs 85%
with BR (n=238) (95% CI: 80.0, 90.0)
Cohort 2: with del(17p)
secondary endpoint†
88% ORRwith BRUKINSA (n=110)
(95% CI: 81.0, 94.0)
*Prespecified analysis assessed by IRC; median follow-up of 26.2 months.2
†Prespecified analysis assessed by IRC; median follow-up of 30.5 months.2
1L=first line; BR=bendamustine+rituximab; CI=confidence interval; HR=hazard ratio; IRC=independent review committee; LDi=longest diameter; ORR=overall response rate; PFS=progression-free survival; VAF=variant allele frequency.
READ THE SEQUOIA (1L) PUBLICATION READ THE SEQUOIA ~5-YEAR MILESTONE ANALYSIS*Prespecified analysis assessed by both IRC and investigator with similar results. Median PFS has not yet been reached with BRUKINSA vs 34 months with ibrutinib.5
†Analyses are exploratory and descriptive in nature.
All subgroup analyses are exploratory and descriptive in nature.
*Assessed by both IRC and investigator with similar results.5
†Median follow-up at the initial analysis: 31 months.1
‡Hazard ratio and 95% CI were unstratified for subgroups.5
Median follow-up: 24.7 months7
With BRUKINSA, 92% of patients sustained a response vs 86% with ibrutinib at 1 year1
Statistical analysis for ORR was conducted for noninferiority. When noninferiority was met, superiority was tested.5
*Assessed by both IRC and investigator with similar results.1,5
Exploratory analyses.
All subgroup analyses are exploratory and descriptive in nature.
Assessed by both IRC and investigator with similar results. Median follow-up of 24.7 months.1,5,7
2L=second line; BTKi=Bruton's tyrosine kinase inhibitor; CI=confidence interval; CR=complete response; CRi=complete response with absolute neutrophil count <1,000/µL; ECOG PS=Eastern Cooperative Oncology Group performance status; HR=hazard ratio; IRC=independent review committee; nPR=nodular partial response; ORR=overall response rate; PFS=progression-free survival; PR=partial response; PR–L=partial response with lymphocytosis.
READ THE ALPINE (2L) PUBLICATION READ THE ALPINE ~3.5-YEAR MILESTONE ANALYSISDr Anthony Nguyen discusses efficacy data across mutations and risk status in CLL
DISCOVER MORE VIDEOSTell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking BRUKINSA with certain other medications may affect how BRUKINSA works and can cause side effects.
These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
BRUKINSA is a prescription medicine used to treat adults with:
It is not known if BRUKINSA is safe and effective in children.
Please see full Prescribing Information including Patient Information.