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Selumetinib

Extended indication Paedriatric (12-18 years of age) neurofibromatosis type-1.
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Selumetinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Neuroendocrine cancer
Extended indication Paedriatric (12-18 years of age) neurofibromatosis type-1.
Manufacturer AstraZeneca
Mechanism of action MEK kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Anti MAPK kinase (MEK).

Registration

Registration route Centralised (EMA)
Submission date June 2020
Expected Registration June 2021
Orphan drug Yes
Registration phase Registration application pending
Additional remarks Fabrikant verwacht een indiening in H1 2020 en registratie in H1 2021.

Therapeutic value

Current treatment options Geen effectieve behandeling beschikbaar.
Therapeutic value No judgement
Duration of treatment Average 30 month / months
Frequency of administration 2 times a day
Dosage per administration 25 mg/m2
References NCT01362803; Dombi A. et al. N. Engl. J. Med. 2016 375:2550-60

Expected patient volume per year

Patient volume

< 500

Market share is generally not included unless otherwise stated.
References NHG; CBS
Additional remarks De incidentie van NF1 bij het aantal levendgeborenen is 1 op de 2.500. Als dit doorberekend wordt naar de populatie van 12 tot 18 jaar dan komt dit neer op een kleine 500 patiënten. Hiervan komt alleen het deel in aanmerking dat niet voldoende behandeld kan worden met een chirurgische ingreep.

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

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Mogelijke indicatie-uitbreiding: Differentiated thyroid cancer - first-line with radioactive iodine
References SPS

Other information

There is currently no futher information available.