EMA Recommends Extension of Therapeutic Indications for Ibrutinib

On 23 June 2022, 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 N.V.

The CHMP adopted an extension to an existing indication to include its use in combination with venetoclax. For information, the full indications for Imbruvica will therefore be as follows (new indication in bold):

  • Ibrutinib as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
  • Ibrutinib as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
  • Ibrutinib 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.
  • Ibrutinib 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.
  • Ibrutinib 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.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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