|
|
|
Blinatumomab (14)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
Acute lymphocytic B-cell leukaemia, Ph-, CD19+, newly diagnosed, adults
|
n.d.
|
active procedure
Orphan (turnover limit)
|
|
|
|
Blinatumomab (13)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
Acute lymphocytic B-cell leukaemia, Ph-, CD19+, high-risk first relapse, children aged ≥1 month
|
n.d.
|
active procedure
Orphan (turnover limit)
|
|
|
|
Blinatumomab (12)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
Acute lymphocytic B-cell leukaemia, Ph-, CD19+, MRD-positive, adults
|
n.d.
|
active procedure
Orphan (turnover limit)
|
|
|
|
Blinatumomab (11)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
Acute lymphocytic B-cell leukaemia, Ph-, CD19+, relapsed/refractory, following ≥ 2 prior treatments or following allogeneic haematopoietic stem cell transplantation, children aged ≥ 1 month
|
n.d.
|
active procedure
Orphan (turnover limit)
|
|
|
|
Blinatumomab (10)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
Acute lymphocytic B-cell leukaemia, CD19+, relapsed or refractory, adults
|
n.d.
|
active procedure
Orphan (turnover limit)
|
|
|
|
Blinatumomab (8)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
Acute lymphoblastic B-cell leukaemia, high-risk first relapse, Ph-, CD19+, ≥1 month and <1 year
|
1
|
100%
Hint for
non-quantifiable additional benefit
Orphan
|
|
|
|
Blinatumomab (9)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
Acute lymphoblastic B-cell leukaemia, Ph-, CD19+, newly diagnosed
|
160–270
|
100%
Hint for
considerable additional benefit
Orphan
|
|
|
|
Blinatumomab (7)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
Acute lymphoblastic B-cell leukaemia, relapsed/refractory, ≥ 1 month to < 1 year, after ≥ 2 prior therapies or after allogeneic stem cell transplantation
|
1
|
100%
Hint for
non-quantifiable additional benefit
Orphan
|
|
|
|
Blinatumomab (6)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
B-cell acute lymphoblastic leukaemia (ALL), high-risk first relapse, Ph-, CD19+, 1 to ≤ 18 years
|
7–30
|
100%
Indication of
major additional benefit
Orphan
|
|
|
|
Blinatumomab (5)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
B-cell acute lymphoblastic leukaemia, relapsed or refractory, Ph+ CD19+
|
5–10
|
100%
Hint for
non-quantifiable additional benefit
Orphan
|
|
|
|
Blinatumomab (4)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
B-cell acute lymphoblastic leukaemia (ALL), MRD-positive patients
|
40–110
|
100%
non-quantifiable additional benefit
Orphan
|
|
|
|
Blinatumomab (3)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
B-cell acute lymphoblastic leukaemia (ALL), ≥ 1 to <18 years
|
30–80
|
100%
non-quantifiable additional benefit
Orphan
|
|
|
|
Blinatumomab (2)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
B-cell acute lymphoblastic leukaemia (ALL)
|
60–170
|
100%
considerable additional benefit
Orphan
|
|
|
|
Blinatumomab (1)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
|
B-cell acute lymphoblastic leukaemia (ALL)
|
0
60–170
|
100%
non-quantifiable additional benefit
Orphan
repealed
|
