*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; Cohort 2: BRUKINSA 74.8 months.5
AE, adverse event; 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; MCL, mantle cell lymphoma; mPFS, median progression-free survival; 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. United Kingdom Summary of Product Characteristics. BeOne Medicines UK Ltd.;
- 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. Abstract 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