Extended indication Behandeling van HER2 positieve borstkanker in combinatie met Capecitabine en Trastuzumab (2L+)
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Tucatinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Breast cancer
Extended indication Behandeling van HER2 positieve borstkanker in combinatie met Capecitabine en Trastuzumab (2L+)
Manufacturer Array BioPharma
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks ERBB 2 receptor antagonists. Fabrikant: Array BioPharma.

Registration

Registration route Centralised (EMA)
Orphan drug No
Registration phase Clinical trials
Additional remarks fase III studie

Therapeutic value

Therapeutic value No judgement
Frequency of administration 2 times a day
Dosage per administration 300 mg
References meerdere fase II studies (zie clinicaltrials.gov), zie o.a. NCT02614794, fase III studie nu ook gestart: NCT03975647

Expected patient volume per year

Patient volume

< 190

Market share is generally not included unless otherwise stated.

References NKR
Additional remarks Er zijn zo'n 190 patiënten per jaar met stadium IV HER+ invasief mammacarcinoom, een deel hiervan zal in de 2e lijn of daarop volgende behandeling in aanmerking komen voor dit geneesmiddel. Aantal patiënten in de tweede lijn zal naar verwachting wel toe gaan nemen door betere overleving.

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 colorectaal carcinoom
References AdisInsight, clinicaltrials.gov

Other information

There is currently no futher information available.