EMA Recommends Extension of Indications for Ibrutinib

New indications concern combination with obinutuzumab for CLL and with rituximab for Waldenström’s macroglobulinaemia

On 27 June 2019, the European Medicines Agency’s (EMA’s) 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 extensions to the existing indications as follows (new text in bold):

  • IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
  • IMBRUVICA as a single agent or in combination with obinutuzumab 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 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. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.

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.