Extended indication Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older w
Therapeutic value Possible added value
Registration phase Positive CHMP opinion

Product

Active substance Blinatumomab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication ALL
Extended indication Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy.
Proprietary name Blincyto
Manufacturer Amgen
Mechanism of action Immunostimulation
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date November 2020
Expected Registration July 2021
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP-opinie in mei 2021.

Therapeutic value

Current treatment options Standaard consolidatie chemotherapie pediatrische ALL
Therapeutic value Possible added value
Substantiation De data uit de gerandomiseerde fase 3 studie is positief. De overall survival (OS) gemeten na 36 maanden was 81,1% voor patiënten behandeld met blinatumomab vergeleken met 55,8% voor patiënten behandeld met chemotherapie.
References Fabrikant; NCT02393859
Additional comments informatie met betrekking tot effectiviteit, behandelduur, toedieningsfrequentie, dosering nog niet beschikbaar

Expected patient volume per year

Patient volume

< 5

Market share is generally not included unless otherwise stated.

References Fabrikant; expert opinie uit Prinses Maxima Centrum
Additional comments Maximaal 5 patiënten

Expected cost per patient per year

References Medicijnkosten.nl; Fabrikant
Additional comments €2.791 per blinatumomab infpdr flacon 38,5μg + solv 10 ml. (inclusief BTW). Uiteindelijke kosten nog afhankelijk van dosering en aantal toedieningen.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.