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IMBRUVICA® is generally well-tolerated across all lines of therapy – as a single agent or in combination with rituximab in WM[1][2]
Well-established long-term tolerability with up to 5 years' follow-up*[1][2]
In the phase 3 iNNOVATE study[1][3]:
- 45% of all patients treated with IMBRUVICA® continued treatment at a follow-up of 5 years[1]
- Fewer discontinuations of either individual treatment with IMBRUVICA® + rituximab due to AEs vs. PBO+R (IMBRUVICA® or PBO: 7% vs. 4%; rituximab: 3% vs. 12%)[3]
- Lower rates of IgM flare with I+R vs. PBO+R (any grade: 8% vs. 47%; Grade ≥3: 0% vs. 3%)[3]
- Lower rates of Grade ≥3 infusion related reactions with I+R vs. PBO+R (1% vs. 16%)[3]
- Consistent safety profile, with a long-term follow-up of up to 5 years[1]
iNNOVATE: Grade ≥3 AEs occurring in ≥10% of patients[3]
In the PCYC-1118e study†[^3]:
- IMBRUVICA® was well tolerated with no unexpected toxicities throughout the long-term follow-up.
- 57% of patients with R/R WM were still on IMBRUVICA® at PCYC-1118e study end (5 years)
PCYC-1118e: Grade ≥2 AEs related to IMBRUVICA®[4]
Reclaim extended survival with meaning: Improved symptom-related QoL†[5]
- Greater and faster IgM decline with I+R vs. PBO+R[1]
- Higher rates of sustained Hb improvement (77% I+R vs. 43% PBO+R)[1]
- Improved symptom-related QoL with I+R[5]
Improvement in the total score of the FACT-An Scale[6]
Improvement in the EQ-5D-5L questionnaire[6]
This content is intended for Healthcare Professionals only. IMBRUVICA® is licensed in the following indications:
- IMBRUVICA® as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
- IMBRUVICA® as a single agent or in combination with rituximab or obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
- IMBRUVICA® as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
- IMBRUVICA® as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemoimmunotherapy.
- IMBRUVICA® in combination with rituximab is indicated for the treatment of adult patients with WM.
Prescribing information may vary depending on approval in each country. Therefore, before prescribing any product, always refer to local materials such as the prescribing information and/or the Summary of Product Characteristics.
*Median follow-up was 50 months in the phase 3 iNNOVATE trial. Median follow-up was 59 months in PCYC-1118e.[1][2]
†Median follow-up was 26.5 months. PRO analyses from iNNOVATE. PRO measures included FACIT-Fatigue, FACT-An total score (TS) and anemia subscale score (AS) and EQ-5D-5L visual analog scale (VAS), and utility score (US). At Week 25, the Pearson correlation coefficients were 0.28, 0.29, and 0.26 for changes in Hb levels vs. changes in FACIT-F, TS and AS, respectively, in the I+R arm; no meaningful correlations were observed with PBO+R. The correlation coefficients were -0.32, -0.33, -0.35 and -0.26 for changes in IgM levels vs. changes in FACIT-F, TS, AS and EQ-VAS, respectively, for I+R and 0.29 and 0.35 vs. FACIT-F and TS, respectively, for PBO+R.[5]
AEs=adverse events; EQ-5D-5L=EuroQol quality of life scale; EQ-VAS=EuroQol Visual analogue scale; FACIT=Functional Assessment of Chronic Illness Therapy – Fatigue; FACT-An=Functional Assessment of Cancer Therapy – Anemia; Hb=haemoglobin; I+R=IMBRUVICA® + rituximab; IgM=immunoglobulin M; PBO+R=placebo + rituximab; PRO=patient-reported outcome; QoL=quality of life; R/R=relapsed/refractory; WM=Waldenström’s macroglobulinemia.
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