Daratumumab

Daratumumab (Darzalex) has 8 EU-approved indications in 2 tumour types.
Approved indications of Daratumumab
Biomarker requirementRegimenSettingConditions
Multiple myeloma7
None
+ bortezomib, lenalidomide and dexamethasone
1L
None
None
+ bortezomib, thalidomide and dexamethasone
1L
Eligible for autologous stem cell transplant
None
+ lenalidomide and dexamethasone, or bortezomib, melphalan and prednisone
1L
Ineligible for autologous stem cell transplant
None
+ lenalidomide and dexamethasone, or bortezomib and dexamethasone
2L
After at least one prior therapy
None
+ pomalidomide and dexamethasone
2L
After one prior therapy containing a proteasome inhibitor and lenalidomide with lenalidomide refractoriness, or at least two prior therapies including lenalidomide and a proteasome inhibitor with disease progression on or after the last therapy
None
Monotherapy
2L
After prior therapy included a proteasome inhibitor and an immunomodulatory agent, and demonstrated disease progression on the last therapy
None
Monotherapy
Any line
Smouldering myeloma only (high risk); High risk of developing multiple myeloma
AL amyloidosis1
None
+ cyclophosphamide, bortezomib and dexamethasone
1L
None
Full text of section 4.1 (therapeutic indications)

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. Multiple myeloma  in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma.  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). 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 (see section 5.1). Light chain (AL) amyloidosis DARZALEX is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic AL amyloidosis.

Label history

48 changes to the Darzalex label since 2017, 9 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes