This medicine is authorised for use in the European Union.


Darzalex is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow). It is used:

  • in combination with the medicines lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone in patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (a transplant of the patient's own blood-producing cells). Bortezomib, lenalidomide and melphalan are used for treating multiple myeloma and dexamethasone and prednisone suppress the immune system;
  • in combination with dexamethasone plus either lenalidomide or bortezomib in patients who have previously received other treatment for the disease;
  • on its own when the disease has come back after treatment with cancer medicines (including medicines known as proteasome inhibitors) and immunomodulatory medicines (that act on the immune system), or when the disease has not improved with these medicines.

Multiple myeloma is rare and Darzalex was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 July 2013.

Darzalex contains the active substance daratumumab

This EPAR was last updated on 08/01/2020

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


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.

Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Turnhoutseweg 30
2340 Beerse

Product information

19/11/2019 Darzalex - EMEA/H/C/004077 - II/0029


Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

  • Antineoplastic agents

  • Monoclonal antibodies

Therapeutic indication

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 combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.v

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
4 ratings