Depatuxizumab mafodotin

Active substance
Depatuxizumab mafodotin
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Brain cancer
Extended indication
Treatment of patients with newly diagnosed EGFR-amplified glioblastoma in combination with temozolomide and radiotherapy.

1. Product

Manufacturer
Abbvie
Mechanism of action
Antibody-drug conjugate
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)

2. Registration

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

3. Therapeutic value

Therapeutic value
No judgement
Duration of treatment
Not found

4. 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 comments
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.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Glioblastoma multiforme, relapsed - second and subsequent line
References
SPS

9. Other information

There is currently no futher information available.