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Depatuxizumab mafodotin

Extended indication Treatment of patients with newly diagnosed EGFR-amplified glioblastoma in combination with temozolom
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Depatuxizumab mafodotin
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Brain cancer
Extended indication Treatment of patients with newly diagnosed EGFR-amplified glioblastoma in combination with temozolomide and radiotherapy.
Manufacturer Abbvie
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks Studie heeft de primaire eindpunten niet gehaald.

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

Patient volume

< 200

Market share is generally not included unless otherwise stated.
References NKR; Hatanpaa et al. Neoplasia. 2010 Sep; 12(9): 675–684
Additional remarks De incidentie ligt jaarlijks rond de 700 en daar komen zeker 100 cases bij na progressie. Als we uitgaan van 40% EGFR-amplificatie en vervolgens 60% van patiënten dat in aanmerking komt voor chemotherapie, dan zijn dat ongeveer 200 cases op jaarbasis.

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 Glioblastoma multiforme, relapsed - second and subsequent line
References SPS

Other information

There is currently no futher information available.