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Blinatumomab

BLINCYTO®

Extended indication Indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with n
Therapeutic value Possible added value
Registration phase Registration application pending

Product

Active substance Blinatumomab
Domain Hematology
Reason of inclusion Indication extension
Main indication ALL
Extended indication Indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD-19 positive B-cell precursor ALL
Proprietary name BLINCYTO®
Manufacturer Amgen
Portfolio holder Amgen
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Powder for solution for infusion
Budgetting framework Intermural (MSZ)
Additional remarks Blinatumomab is een bispecifiek T-cel-engager-antilichaamconstruct dat specifiek bindt aan CD19

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2024
Expected Registration January 2025
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options Intensieve combinatiechemotherapie zoals beschrven in het HOVON100 protocol (1)
Therapeutic value Possible added value
Substantiation De ECOG-ACRIN E1910-studie toonde aan dat de toevoeging van blinatumomab aan consolidatiechemotherapie resulteerde in een significant betere algehele overleving bij patiënten met nieuw gediagnosticeerde B-lineage ALL die MRD-negatief waren na intensiveringschemo (mediane OS: niet bereikt versus 71,4 maanden; Hazard ratio 0,42, 95% BI: 0,24 - 0,75; two-sided p=0,003). Mediane follow-up was 43 maanden). Er werden geen significante veiligheidszorgen opgemerkt (2,3).
References Richtlijn acute lymfatische leukemie Diagnostiek en behandeling. Organisatie HOVON leukemie werkgroep. 2020 (1); Litzow et al. N Engl J Med. 2024 (2). NCT02003222 (ECOG-ACRIN E1910) (3).
Additional remarks Continuous blinatumomab IV for 28 days for maximum 4 cycles. 1 cycle consist of 28 days IV infusion with a fixed dosing of 28mg/day.

Expected patient volume per year

Patient volume

< 33

Market share is generally not included unless otherwise stated.
References NKR; Expertopinie
Additional remarks Het geschatte aantal in aanmerking komende patiënten met Ph-precursor B-cel ALL die MRD- zijn na inductie en intensivering, wordt geschat op 33.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension No

Other information

There is currently no futher information available.