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New treatment licenced for rare lymphoma

written by

Leukaemia Care, Charity

  • medication

Last week the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended a change to the marketing authorisation for ibrutinib to include a new indication. Ibrutinib is marketed by Janssen-Cilag as Imbruvica® and has been recommended for the following indication:

“Imbruvica 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 chemo-immunotherapy.”

Waldenström’s macroglobulinaemia (WM) is a rare type of non-Hodgkin lymphoma. Common symptoms include night sweats, anaemia, unexplained weight loss, tiredness, unexplained infections and headaches. Unlike many other types of non-Hodgkin lymphoma people with WM do not often have swelling of their lymph nodes or spleen.

Ibrutinib is also licenced for “the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)” and for “the treatment of 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 in patients unsuitable for chemo-immunotherapy”.

A copy of the EMA opinion is available here.

If you are affected by these changes and would like to speak to somebody about it, please call our 24-hour CARE Line on 08088 010 444.

For more information on Waldenström’s macroglobulinaemia, please visit