Darzalex

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daratumumab

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

Overview

Darzalex is a medicine used to treat adults with multiple myeloma (a cancer of the bone marrow) and light chain (AL) amyloidosis (a blood disease in which deposits of abnormal proteins, called amyloids, accumulate and cause damage in tissues and organs).

Multiple myeloma

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;
  • in combination with pomalidomide and dexamethasone when the disease has not improved with lenalidomide in combination with cancer medicines known as proteasome inhibitors, or when the disease has come back after at least two therapies with these medicines;
  • on its own when the disease has come back after treatment with cancer medicines (including proteasome inhibitors) and immunomodulatory medicines (that act on the immune system), or when the disease has not improved with these medicines.

AL amyloidosis

For AL amyloidosis, this medicine is for patients newly diagnosed with the condition and is used in combination with cyclophosphamide, bortezomib and dexamethasone.

Multiple myeloma and AL amyloidosis are 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 on the Agency’s website (Multiple myeloma: 17 July 2013, AL amyloidosis: 25 May 2018).

Darzalex contains the active substance daratumumab.

This EPAR was last updated on 11/07/2022

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
L01FC01
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.

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
19
Date of issue of marketing authorisation valid throughout the European Union
20/05/2016
Contact address

Turnhoutseweg 30
2340 Beerse
Antwerp
Belgium

Product information

30/06/2022 Darzalex - EMEA/H/C/004077 - IB/0061/G

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Antineoplastic agents

  • monoclonal antibodies and antibody drug conjugates

Therapeutic indication

Multiple Myeloma

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.
  • in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1).
  • 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.

AL Amyloidosis

DARZALEX is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.

Assessment history

Changes since initial authorisation of medicine

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