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Daromun

Nidlegy

Extended indication Neoadjuvant intratumoral treatment in clinical stage IIIB/C melanoma
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Daromun
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Skin cancer
Extended indication Neoadjuvant intratumoral treatment in clinical stage IIIB/C melanoma
Proprietary name Nidlegy
Manufacturer Sun Pharma
Mechanism of action Immunostimulation
Route of administration Intratumoral
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date September 2024
Expected Registration October 2025
Orphan drug No
Registration phase Clinical trials
Additional remarks NCT03567889

Therapeutic value

Current treatment options Er is nog geen vergelijkbare behandeloptie als standaardzorg beschikbaar. Ook darleukin fibromun komt mogelijk snel op de markt.
Therapeutic value No estimate possible yet
Substantiation De resultaten uit de fase 3 studie zijn nog niet bekend.
Duration of treatment Average 4 week / weeks
Frequency of administration 1 times a week
References NCT03567889, NCT02938299

Expected patient volume per year

Patient volume

< 778

Market share is generally not included unless otherwise stated.
References IKNL 2021
Additional remarks Melanoom van de huid en lip betreft in totaal 7.670 patiënten in 2021. Dit betreft 695 patiënten in stadium III en 83 in stadium IV (1). Enkel patiënten met operabele ziekte komen in aanmerking. Daarnaast zullen niet alle patiënten die chirurgisch behandeld worden ook dit geneesmiddel krijgen (2).

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.