Questions & Answers
On 23 February 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending changes to the terms of the marketing authorisation for the medicinal product Darzalex. The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV.
The CHMP adopted an extension to the existing indication as follows1:
"Darzalex is indicated:
- as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
- in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy."
In addition, since all specific obligations of the conditional marketing authorisation have been fulfilled, the marketing authorisation for Darzalex will be switched from conditional to full approval.
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.
1New text in bold
|Name||Language||First published||Last updated|
|CHMP post-authorisation summary of positive opinion for Darzalex||(English only)||2017-02-24|
|INN or common name|
|Therapeutic area||Multiple Myeloma|
|Date opinion adopted||23/02/2017|
Janssen-Cilag International N.V.
|Application type||Post authorisation|