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
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 2023
Expected Registration 2024
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

Patient volume

< 775

Market share is generally not included unless otherwise stated.

References NKR
Additional comments Melanoom van de huid betreft 6.746 patiënten in 2020, hiervan zijn er 687 patiënten met stadium 3. 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.