An Oral, Once-Daily MCL Treatment Option For Patients: IMBRUVICA® (ibrutinib)
IMBRUVICA® (ibrutinib) is indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Because of how IMBRUVICA® works, it may cause side effects.1
You may experience changes in your white blood cell count
After starting IMBRUVICA®, your doctor will monitor your blood cell counts.1 Your lab results may show an increase in lymphocytes, a type of white blood cell. This is called lymphocytosis, and it can occur with IMBRUVICA® treatment. In the absence of other signs and symptoms, this increase may not necessarily mean your condition is worsening.4
In 3 clinical trials, 66% of people with CLL developed lymphocytosis. This typically occurred during the first month of IMBRUVICA® therapy and resolved by a median* of 14 weeks, ranging from 0.1 to 104 weeks. When IMBRUVICA® was administered with chemoimmunotherapy, lymphocytosis was 7% with IMBRUVICA® + BR versus 6% with placebo + BR.1
Talk to your doctor about what your test results mean.
*Median is the middle number in a group of numbers that are arranged from lowest to highest. For example, in the group of numbers 1-11, 6 is the median.
References: 1. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC. 2017. 2. de Rooij MF, Kuil A, Geest CR, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood. 2012;119(11):2590-2594. 3. Advani RH, Buggy JJ, Sharman JP, et al. Bruton tyrosine kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. J Clin Oncol. 2013;31(1):88-94. 4. Cheson BD, Byrd JC, Rai KR, et al. Novel targeted agents and the need to refine clinical end points in chronic lymphocytic leukemia. J Clin Oncol. 2012;30(23):2820-2822. 5. Genetics Home Reference. What is isolated growth hormone deficiency? http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed August 23, 2017.
Response rates in previously treated mantle cell lymphoma (MCL)
Primary endpoint: 65.8% of patients treated with IMBRUVICA® (ibrutinib)
achieved a response in the phase 2 clinical trial1
Two of three patients experienced a response with IMBRUVICA®1
Median time to response was 1.9 months1
- The responses were assessed by investigators using criteria according to the revised International Working Group criteria for non-Hodgkin lymphoma
PR=partial response; CR=complete response; CI=confidence interval.
- 17.1% of patients achieved a CR1
- Overall response rate (ORR) was assessed according to the revised International Working Group for non‑Hodgkin's lymphoma criteria1
- Based on an Independent Review Committee, ORR assessment was 69%1
Reference: 1. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC. 2017.
