The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion, recommending broadening the existing marketing authorisation for Imbruvica ( Ibrutinib ) as a single agent for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia ( CLL ).
Imbruvica is approved for the treatment of adult patients with relapsed or refractory mantle cell lymphoma ( MCL ), or adult patients with chronic lymphocytic leukaemia ( CLL ) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation ( genetic mutations typically associated with poor treatment outcomes ) in patients unsuitable for chemo-immunotherapy and in adult patients with Waldenström’s macroglobulinemia ( WM ) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
The positive opinion of the CHMP was based on data from the phase 3, randomised, open-label RESONATE-2 clinical trial.
Findings showed Ibrutinib provided a significant improvement in all efficacy endpoints versus Chlorambucil in patients aged 65 or older with newly diagnosed chronic lymphocytic leukaemia.
The progression-free survival ( PFS ) rate at 18 months was 90% for Ibrutinib versus 52% for Chlorambucil.
Ibrutinib also significantly prolonged overall survival ( OS ) ( HR=0.16; 95% CI, 0.05, 0.56; P=0.001 ), with a 24-month survival rate of 98%, compared to 85% for patients in the Chlorambucil arm.
The safety of Ibrutinib in the treatment-naïve CLL patient population was consistent with previously reported studies. The most common adverse reactions ( greater than or equal to 20% ) of any grade in the RESONATE-2 trial for Ibrutinib were diarrhoea ( 42% ), fatigue ( 30% ), cough ( 22% ) and nausea ( 22% ).
Ibrutinib is a first-in-class Bruton's tyrosine kinase ( BTK ) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B cells. By blocking this BTK protein, Ibrutinib helps kill and reduce the number of cancer cells. It also slows down the progression of the cancer.
In most patients, chronic lymphocytic leukaemia is generally a slow-growing blood cancer of the white blood cells called B-lymphocytes. The median age at diagnosis is 72 years, and incidence rates among men and women in Europe are approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.
Chronic lymphocytic leukaemia is a chronic disease; median overall survival ranges between 18 months and more than 10 years according to the stage of disease. The disease eventually progresses in the majority of patients, and patients are faced with fewer treatment options each time. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments. ( Xagena )
Source: Janssen, 2016