Basic Information
Darzalex
Regulatory Information
EMEA/H/C/004077
May 20, 2016
March 31, 2016
24
April 10, 2025
Company Information
Belgium
Turnhoutseweg 30 Beerse 2340 Antwerp
Janssen-Cilag International NV
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma. \- 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. Light chain (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. 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.
Overview Summary
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 an autologous stem cell transplant (a transplant of the patient’s own blood-producing cells). Bortezomib, lenalidomide and melphalan are used to treat multiple myeloma, while dexamethasone and prednisone suppress the immune system; - in combination with bortezomib, lenalidomide and dexamethasone; - in combination with bortezomib, thalidomide (another medicine to treat multiple myeloma) and dexamethasone in patients who can have an 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 (another medicine to treat multiple myeloma) and dexamethasone when the disease has not improved with lenalidomide in combination with cancer medicines known as proteasome inhibitors, or when the disease has worsened after at least two treatments 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 used in patients newly diagnosed with the condition, 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. Further information on the orphan designations can be found on the Agency’s website ( [multiple myeloma](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1153): 17 July 2013, [AL amyloidosis](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3182020): 25 May 2018). Darzalex contains the active substance daratumumab.