Research & Development
Janssen Gains European Commission Approval of Imbruvica for Expanded Use in Two Indications
14 August 2019 - - The European Commission has approved variations to broaden the use of Imbruvica(ibrutinib) in two indications, US-based healthcare company Johnson and Johnson's (NYSE: JNJ) Janssen Pharmaceutical business said.

This includes the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia and the use of ibrutinib plus rituximab for the treatment of adult patients with Waldenström's macroglobulinemia. 

The approval follows the Positive Opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use on 28 June 2019.

The approval in CLL was based on results from the Phase 3 iLLUMINATE (PCYC-1130) study, published in The Lancet Oncology, which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with previously untreated CLL.

In WM, the decision was based on data from the Phase 3 iNNOVATE (PCYC-1127) study, published in the New England Journal of Medicine.

The study evaluated the efficacy and safety of ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.

Ibrutinib, a first-in-class Bruton's tyrosine kinase inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.

Dr Alessandra Tedeschi is co-investigator in both the iNNOVATE and iLLUMINATE studies. She was not compensated for any media work.

Ibrutinib is a first-in-class Bruton's tyrosine kinase 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 decreases survival and migration of B lymphocytes, thereby delaying progression of the cancer.

Chronic lymphocytic leukaemia is typically a slow-growing blood cancer of the white blood cells.9 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.

CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.

The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

Waldenström's macroglobulinemia is a rare form of non-Hodgkin's lymphoma.

It causes overproduction of a protein called monoclonal immunoglobulin M antibody, which causes a thickening of the blood.

Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.

The causes of WM are unknown, with it typically affecting older adults and being slightly more common in men than women.


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