Darzalex is a medicine used in adults to treat the following conditions. . **Multiple myeloma** Darzalex is used to treat adults with multiple myeloma, a cancer of the bone marrow that affects a type of white blood cell called plasma cells, which normally help fight infections. In patients with newly diagnosed multiple myeloma, Darzalex 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, Darzalex 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. **Smouldering multiple myeloma** Darzalex is used on its own to treat adults with smouldering multiple myeloma, an early, pre‑cancerous form of multiple myeloma with abnormal plasma cells in the bone marrow. It is used in patients whose disease has a high risk of progressing to multiple myeloma. **Light chain (AL) amyloidosis** Darzalex is used in patients newly diagnosed with AL amyloidosis, a blood disease in which deposits of abnormal proteins, called amyloids, accumulate and cause damage in tissues and organs. It 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. 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.
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). - in 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. **Smouldering multiple myeloma** Darzalex as monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma. **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.
Therapeutic Area (MeSH)
ATC Code
L01FC01
ATC Item
daratumumab
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
EMA Name
Darzalex
Medicine Name
Darzalex
Aliases
N/A
