Imbruvica

ibrutinib

Opinion

On 27 June 2019, the 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 Imbruvica. The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV.

The CHMP adopted extensions 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 or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).

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. 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 (SmPC), which will be published in the revised European public assessment report (EPAR), 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.


*New text in bold

Key facts

Name
Imbruvica
Agency product number
EMEA/H/C/003791
International non-proprietary name (INN) or common name
  • ibrutinib
Active substance
  • Ibrutinib
Therapeutic area
Lymphoma, Mantle-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
28/06/2019
Company name
Janssen-Cilag International NV
Status
Positive
Application type
Post-authorisation

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