EMA Recommends Extensions of Indication for Daratumumab

New indication concern combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone in patients with multiple myeloma who have received at least one prior therapy

On 23 February 2017, the European Medicines Agency’s (EMA’s) 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 daratumumab (Darzalex).

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

The CHMP adopted an extension to the existing indication as follows (new text in bold):

“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, 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.