EMA Recommends Extension of Therapeutic Indications for Ibrutinib

The changes in marketing authorisation concern the treatment of mantle cell lymphoma, chronic lymphocytic leukaemia and Waldenström’s macroglobulinaemia
02 Aug 2016

On 21 July 2016, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product ibrutinib (Imbruvica).

The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV.

The CHMP adopted changes to the existing indications as follows:

“IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

IMBRUVICA as a single agent is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

IMBRUVICA as a single agent 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.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Last update: 02 Aug 2016

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