Selumetinib

Active substance

Selumetinib

Domain

Oncology and Hematology

Reason of inclusion in Horizonscan Geneesmiddelen

New medicine (specialité)

Main indication

Neuroendocrine cancer

Extended indication
Paedriatric (12-18 years of age) neurofibromatosis type-1.

Product

Manufacturer

AstraZeneca

Mechanism of action

MEK kinase inhibitor

Route of administration

Oral

Therapeutical formulation

Capsule

Budgetting framework

Intermural (MSZ)

Additional comments
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 comments
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 comments
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.