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Selumetinib

Extended indication Neurofibromatosis type 1
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Selumetinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Neuroendocrine cancer
Extended indication Neurofibromatosis type 1
Manufacturer AstraZeneca
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Anti MAPK kinase (MEK).

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

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 Dombi A. et al. N. Engl. J. Med. 2016 375:2550-60

Expected patient volume per year

Patient volume

< 6,000

Market share is generally not included unless otherwise stated.
References NHG
Additional remarks Er zijn in Nederland 4.000-6.000 patiënten met NF1.

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.