Darzalex is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow). In patients with newly diagnosed multiple myeloma it is used:
- in combination with the medicines lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone in patients who cannot have 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 bortezomib, thalidomide (another medicine used to treat multiple myeloma), and dexamethasone, in patients who can have autologous stem cell transplant.
In patients with previously treated multiple myeloma it is used:
- in combination with dexamethasone plus either lenalidomide or bortezomib;
- 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. Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Darzalex contains the active substance daratumumab.
Darzalex : EPAR - Medicine overview (PDF/160.39 KB)
First published: 27/05/2016
Last updated: 23/01/2020
Darzalex : EPAR - Risk-management-plan summary (PDF/41.59 KB)
First published: 21/09/2018
Last updated: 08/01/2020
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|International non-proprietary name (INN) or common name||
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|Anatomical therapeutic chemical (ATC) code||
Janssen-Cilag International N.V.
|Date of issue of marketing authorisation valid throughout the European Union||
20/01/2020 Darzalex - EMEA/H/C/004077 - II/0030
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Darzalex is indicated:
- 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.
- in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
- 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.
- 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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 201913/12/2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 201918/10/2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 201724/02/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 29 March - 1 April 201601/04/2016