|
|
|
Daratumumab (15)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Smouldering multiple myeloma (SMM)
|
160–325
|
100%
Hint for
minor additional benefit
Orphan (turnover limit)
|
|
|
|
Daratumumab (14)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Multiple myeloma, unsuitable for stem cell transplantation, in combination with bortezomib, lenalidomide and dexamethasone
|
3,450–3,680
|
100%
Hint for
minor additional benefit
Orphan (turnover limit)
|
|
|
|
Daratumumab (13)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Systemic light-chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone
|
220–515
|
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
|
|
|
|
Daratumumab (12)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Multiple myeloma, first-line, stem cell transplantation suitable, combination with bortezomib, lenalidomide and dexamethasone
|
1,750–1,910
|
100%
additional benefit not proven
Orphan (turnover limit)
|
|
|
|
Daratumumab (11)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Multiple myeloma, first-line, stem cell transplantation unsuitable, combination with bortezomib, melphalan and prednisone
|
3,450–2,680
|
100%
Indication of
considerable additional benefit
Orphan (turnover limit)
|
|
|
|
Daratumumab (10)
|
Darzalex®
|
Janssen
|
Oncological diseases
|
Multiple myeloma (MM), after at least 1 previous therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone
|
4,700–7,000
|
100%
Proof of
considerable additional benefit
Orphan (turnover limit)
|
|
|
|
Daratumumab (9)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone
|
3,470–3,670
|
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
|
|
|
|
Daratumumab (8)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Multiple Myeloma (MM), at least 1 pretreatment, combination with Pomalidomid and Dexamethason
|
3,190–3,600
|
38%
Hint for
minor additional benefit
Orphan (turnover limit)
|
|
|
|
Daratumumab (7)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Systemic light chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone
|
0
440–1,030
|
50%
Hint for
minor additional benefit
Orphan (turnover limit)
repealed
|
|
|
|
Daratumumab (5)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone
|
0
3,479–3,670
|
100%
Hint for
minor additional benefit
Orphan (turnover limit)
repealed
|
|
|
|
Daratumumab (6)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Multiple myeloma (MM), newly diagnosed, patients suitable for autologous stem cell transplantation, combination with bortezomib, thalidomide and dexamethasone
|
1,800–1,900
|
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
|
|
|
|
Daratumumab (4)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Multiple myeloma (MM), first-line, unsuitable for stem cell transplantation, combination with bortezomib, melphalan and prednisone
|
0
3,380–3,900
|
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
repealed
|
|
|
|
Daratumumab (3)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Multiple myeloma (MM), monotherapy; multiple myeloma, at least 1 prior therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone
|
2,300
7,000–9,300
|
72%
Indication of
considerable additional benefit
Orphan (turnover limit)
repealed subpopulations
|
|
|
|
Daratumumab (2)
|
Darzalex®
|
Janssen Cilag GmbH
|
Oncological diseases
|
Multiple myeloma (MM)
|
n.d.
|
discontinued
Orphan
|
|
|
|
Daratumumab (1)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Multiple myeloma (MM), monotherapy, pre-treated patients
|
0
2,300
|
100%
non-quantifiable additional benefit
Orphan
repealed
|
