Darzalex

RSS

daratumumab

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 23/01/2020

Authorisation details

Product details
Name
Darzalex
Agency product number
EMEA/H/C/004077
Active substance
Daratumumab
International non-proprietary name (INN) or common name
daratumumab
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01XC24
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.

OrphanOrphan

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.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
28/04/2017
Contact address
Turnhoutseweg 30
2340 Beerse
Belgium

Product information

20/01/2020 Darzalex - EMEA/H/C/004077 - II/0030

Contents

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Pharmacotherapeutic group

  • Antineoplastic agents

  • Monoclonal antibodies

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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