[A26-58] Blinatumomab (B-ALL, refractory or relapsed, children and adolescents >= 1 month) – Benefit assessment according to §35a Social Code Book V

Last updated 01.09.2026

Project no.:
A26-58

Commission:
Commission awarded on 29.05.2026 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

Indication:

Paediatric patients aged 1 month or older with Philadelphia chromosome-negative CD19+ B-cell precursor acute lymphoblastic leukaemia which is refractory or in relapse after receiving at least 2 prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation

Result of dossier assessment:

Added benefit not proven

Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

DOI:

https://doi.org/10.60584/A26-58

Project no.	Title	Status
G15-15	Blinatumomab - Assessment according to §35a (para. 1., sentence 10) Social Code Book V	Commission completed
G17-04	Blinatumomab (acute lymphoblastic leukaemia)- Assessment according to §35a (para. 1., sentence 10) Social Code Book V (expiry of the decision)	Commission completed
G19-07	Blinatumomab (ALL, paediatric patients) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V	Commission completed
G19-08	Blinatumomab (ALL, MRD-positive patients) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V	Commission completed
G21-23	Blinatumomab (acute lymphoblastic leukaemia, Ph-, CD19+, children aged 1 to 18 years) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V	Commission completed
G21-04	Blinatumomab (acute lymphoblastic leukaemia) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V	Commission completed
G25-07	Blinatumomab (refractory ALL, children < 1 year) – Assessment according to §35a (para. 1, sentence 11) Social Code Book V	Commission completed
G25-08	Blinatumomab (first relapsed ALL, children < 1 year) – Assessment according to §35a (para. 1, sentence 11) Social Code Book V	Commission completed
A26-57	Blinatumomab (B-ALL, relapsed or refractory) – Benefit assessment according to §35a Social Code Book V	Commission completed
A26-61	Blinatumomab (B-ALL, newly diagnosed, consolidation therapy) – Benefit assessment according to §35a Social Code Book V	Commission completed
A26-60	Blinatumomab (B-ALL, high-risk first relapsed, children and adolescents >= 1 month) – Benefit assessment according to §35a Social Code Book V	Commission completed
A26-59	Blinatumomab (B-ALL, 1st and 2nd complete remission) – Benefit assessment according to §35a Social Code Book V	Commission completed

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