Extended indication Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C Melanoma Patients.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Darleukin fibromun
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Skin cancer
Extended indication Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C Melanoma Patients.
Manufacturer Philogen
Mechanism of action Angiogenesis inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times a week
References NCT03567889

Expected patient volume per year

References IKNL data
Additional comments In 2016 waren er in totaal 419 patiënten in Nederland met een melanoom in stadium III. Gezien de indicatie geldt voor stadium IIIB en C, komt slechts een gedeelte van de patiëntpopulatie in aanmerking.

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
References Adisinsight

Other information

There is currently no futher information available.