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European Commission Approves ibrutinib/IMBRUVICA®

written by

Leukaemia Care, Charity

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The European Commission has approved the use of ibrutinib, which is a once-daily oral tyrosine kinase inhibitor (TKI), for the treatment of chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma (MCL). It is marketed in Europe by Janssen EMEA (Europe, Middle East and Africa) as IMBRUVICA®. This approval allows for the marketing of ibrutinib in all 28 countries of the European Union for its specifically approved uses. However, ibrutinib still requires approval from the National Institute for Health and Care Excellence (NICE) before it can be prescribed in England.

Ibrutinib works by blocking Bruton’s tyrosine kinase (BTK), which is a protein that helps certain cancer cells live and grow. By blocking this BTK protein ibtrutinib helps kill and reduce the number of leukaemic cancer cells, which will slow down the worsening of the cancer.

The European Commission approval covers the use of ibrutinib in adult patients with relapsed or refractory MCL; adult patients with CLL who have received at least one prior therapy; and first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

Mantle cell lymphoma is a rare type of non-Hodgkin’s B-cell lymphoma usually diagnosed in people over the age of 60, although its causes are unknown. Chronic lymphocytic leukaemia develops very slowly and is the most common type of leukaemia.

View the announcement from Janssen EMEA here.