*Defined as ≥65 years, or 18–64 years with one of the following: CIRS score >6, creatinine clearance <70 mL/min, or severe or frequent infections during the course of illness.3
†Such as recent myocardial infarction, unstable angina, severe congestive heart failure, uncontrolled hypertension or uncontrolled arrhythmias.3
‡Median duration of exposure: Cohort 1 BRUKINSA 71.8 months, BR 6.0 months; Cohort 2: BRUKINSA 74.8 months.5
AE, adverse event; AESI, adverse event of special interest; BID, twice daily; BR, bendamustine + rituximab; BTK, Bruton’s tyrosine kinase; CI, confidence interval; CIRS, Cumulative Illness Rating Scale; CIT, chemo-immunotherapy; CLL, chronic lymphocytic leukaemia; COVID-19, coronavirus disease 2019; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; FCR, fludarabine-cyclophosphamide-rituximab; FISH, fluorescence in situ hybridisation; GI, gastrointestinal; HR, hazard ratio; IGHV, immunoglobulin heavy chain variable region; IRC, independent review committee; iwCLL, International Workshop on CLL; MZL, marginal zone lymphoma; NS, not stated; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; QoL, quality of life; R, randomisation; SLL, small lymphocytic lymphoma; TN, treatment-naïve; WM, Waldenström’s macroglobulinaemia.
References:
- BRUKINSA. European Union Summary of Product Characteristics. BeOne Medicines Ireland Limited;
- Tam CS, et al. Blood Cancer J. 2023;13(1):141;
- Tam CS, et al. Lancet Oncol. 2022;23(8):1031–1043;
- Shadman M, et al. J Clin Oncol. 2025;43(7):780–787;
- Tam C, et al. ASH annual meeting 2025, December 6–9. Poster 2129;
- Ghia P, et al. Curr Med Res Opin. 2023;39(11):1505–1511;
- Tam CS, et al. Expert Rev Clin Pharmacol. 2021;14(11):1329–1344;
- Brullo C, et al. Int J Mol Sci. 2021;22(14):7641;
- Shadman M, et al. Lancet Haematol. 2023;10(1):e35–e45;
- Guo Y, et al. J Med Chem. 2019;62(17):7923–7940;
- Imbruvica. Summary of Product Characteristics. Pharmacyclics LLC, Janssen Biotech, Inc;
- Calquence. Summary of Product Characteristics. AstraZeneca Pharmaceuticals LP.
The study is registered with ClinicalTrials.gov: NCT03336333
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Adverse events should be reported. Ireland: Healthcare professionals are asked to report any suspected adverse reactions via HPRA found at www.hpra.ie. Adverse events should also be reported to BeOne Medicines at https://beonemedicines.co.uk/report-adverse-event/
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