IMBRUVICA offers a wealth of experience for your CLL patients1-3,6,11
Find out more below
Early Use of Imbruvica
Imbruvica® first in the Relapsed/Refractory CLL treatment sequence can make for an efficacious
treatment and provides meaningful patient benefits.1,3,4 Early use of Imbruvica® is
supported by both published literature and real-world evidence.1,3-5
Tolerability - IMBRUVICA is generally
well-tolerated over the long term
AEs are generally low Grade in the long term1,2,19
Incidence of most AEs (except hypertension) generally diminishes over time1-3,19
Dose adjustments and discontinuations due to AEs are infrequent and occur mostly in the first year of
treatment1,2*
IMBRUVICA clinical trials have included a variety of CLL patients, with 5 CLL studies including
high-risk patients such as those with del(17p) or del(11q)1-3, 7,9
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse
events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com
References
Munir T, et al. Final analysis from RESONATE: up to 6 years of follow-up on ibrutinib
in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Am J
Hematol 2019;94(12):1353-1363.
Burger JA, et al. Long-term efficacy and safety of first-line ibrutinib treatment for
patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 Study. Leukemia 2020; 34:787-798
Byrd J.C. et al. 2020. Ibrutinib Treatment for First-Line and Relapsed/Refractory
Chronic Lymphocytic Leukemia: Final Analysis of the Pivotal Phase 1b/2 PCYC-1102 Study. Clinical cancer
research.2020; 26 (15) p.3918-3927
Barr P, et al. Using Ibrutinib in Earlier Lines of Treatment Results in Better Outcomes for Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Poster Presented at the American Society of Hematology Annual Meeting (ASH) December 7–10, 2019; 134 (Suppl) p.3054-3054
Follows G, et al. UK CLL Forum 5 year update on 315 relapsed refractory CLL patients treated with ibrutinib in 66 UK and Ireland centres. Abstract presented at the 61st ASH Annual Meeting & Exposition; 7−10 December 2019; Orange County Convention Center (OCCC), Orlando, FL, USA.
Fraser et al. Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus
bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small
lymphocytic lymphoma, Leukemia & Lymphoma, 2020; DOI: 10.1080/10428194.2020.1795159
O'Brien SM, et al. Ibrutinib for patients with relapsed or refractory chronic
lymphocytic leukemia with 17p deletion (RESONATE-17): a phase 2, open-label, multicentre study. Lancet
Oncol 2016;17(10):1409–1418.
Woyach JA, et al. Ibrutinib regimens versus chemoimmunotherapy in older patients with
untreated CLL. N Eng J Med 2018;379(26):2517–2528.
Moreno C, et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab as
first-line treatment in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma: up to
4 years of extended follow-up from the phase iLLUMINATE study. Poster presented at the XVIII
International Workshop on CLL (iwCLL) Meeting; 20-23 September 2019;Edinburgh, Scotland. #2069.
Rule S, et al. Ibrutinib versus temsirolimus: 3-year follow-up of patients with
previously treated mantle cell lymphoma from the phase 3, international, randomized, open-label RAY
study. Leukemia 2018;32(8):1799–1803.
Rule S, et al. Ibrutinib for the treatment of relapsed/refractory mantle cell
lymphoma: Extended 3.5-year follow-up from a pooled analysis. Haematologica 2019;104(5):e211−e214.
Treon SP, et al. Ibrutinib monotherapy produces long-term disease control in
previously treated Waldenstrom's macroglobulinemia. Final report of the pivotal trial. Haem Onc
2019;37(S2):184–185.
Buske C, et al. Ibrutinib treatment in Waldernström's macroglobulinemia: follow-up
efficacy and safety from the iNNOVATETM study. Oral presentation at the 60th ASH Annual Meeting &
Exposition; 1−4 December 2018; San Diego, CA, USA.
IMBRUVICA® UK Summary of Product Characteristics. Janssen-Cilag Limited.
August 2020
Barr PM, et al. Final analysis from RESONATE: 6-year follow-up in patients with
previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma on ibrutinib. Poster
presented at the American Society of Clinical Oncology (ASCO) Annual Meeting; 31 May−4 June 2019
Chicago, IL, USA.
Byrd JC, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid
leukemia. N Engl J Med 2014;371(3):213−223
Jones JA, et al. Use of anticoagulants and antiplatelet in patients with chronic
lymphocytic leukaemia treated with single-agent ibrutinib. Br J Haematol 2017; 178:286−291.
(supplementary information).
Dartigeas C, et al. French ibrutinib observational study (FIRE): real-world study of
ibrutinib treatment for chronic lymphocytic leukemia (CLL) in France. HaemaSphere 2019;3:145−146
O'Brien SM, et al. Safety analysis of four randomized controlled studies of ibrutinib
in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma or mantle cell lymphoma. Clin
Lymphoma Myeloma Leuk 2018;18(10:648–657.)
Janssen Data on File. Ibrutinib - global number of cumulative patients treated with
Ibrutinib since launch. July 2020
Jain P, et al. Long-term outcomes for patients with chronic lymphocytic leukaemia who
discontinue ibrutinib. Cancer 2017;15(123):2268–2273
Mato AR, et al. Optimal sequencing of ibrutinib, idelalisib and venetoclax in CLL:
Results from a large mutlicenter study of 683 US patients. Ann Oncol 2017;28(5):1050–1056 (Supplementary
Appendix)
Barrientos JC, et al. Improvement in parameters of hematologic and immunologic
function and patient well-being in the phase III RESONATE study of ibrutinib versus ofatumumab in
patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma. Clin Lymphoma
Myeloma Leuk 2018;18(12):803−813.e7.
CLL Patient Voices Survey Final Report. Janssen.
https://janssen.com/emea/sites/www_janssen_com_emea/files
cll_patient_voices_survey_results_presenation_2018_05_13.pdf. Last Accessed October 2020.