Extended indication Differentiated thyroid cancer - first-line with radioactive iodine
Therapeutic value No judgement
Registration phase Withdrawn

Product

Active substance Selumetinib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Thyroid cancer
Extended indication Differentiated thyroid cancer - first-line with radioactive iodine
Manufacturer AstraZeneca
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Anti MAPK kinase (MEK)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Orphan drug No
Registration phase Withdrawn
Additional remarks De ASTRA trial heeft zijn primaire eindpunten niet gehaald.

Therapeutic value

Current treatment options Geen toevoeging RAI behandeling
Therapeutic value No judgement
Duration of treatment Median 5 week / weeks
Frequency of administration 2 times a day
Dosage per administration 5 mg
References NCT02393690
Additional remarks Behandelduur maximaal 5 weken

Expected patient volume per year

Patient volume

< 114

Market share is generally not included unless otherwise stated.

References NKR
Additional remarks 114 diagnoses schildklierkanker stadium 4. Doordat het echter onduidelijk is in welke lijn dit middel ingezet gaat worden is het lastig om een reëel patiëntaantal in te schatten. Het zal naar verwachting een klein deel van deze patiëntengroep bedragen.

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 No

Other information

There is currently no futher information available.