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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 Registration application pending

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 Philogen
Mechanism of action Immunostimulation
Route of administration Intratumoral
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Nidlegy is een combinatie van immunocytokines bifikafusp alfa (L19IL2) en onfekafusp alfa (L19TNF).

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date June 2024
Expected Registration July 2025
Orphan drug No
Registration phase Registration application pending
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 PIVOTAL study NCT02938299: The primary outcome analysis shows an HR between the RFS of the treatment and control arm of 0.59 [95% CI 0.41-0.86; log-rank p=0.005] as per BICR assessment and 0.61 [0.41-0.92; p=0.018] as per investigator assessment (power = 85%; two-sided α = 0.05). Median RFS was 16.7 mo. in the treatment and 6.9 mo. in the control arm as per BICR. Nog geen resultaten van NeoDREAM studie. De plaatsbepaling is nog onduidelijk door wijziging adjuvante behandeling gedurende de loop van de studie.
Duration of treatment Average 4 week / weeks
Frequency of administration 1 times a week
References NCT03567889 (NeoDREAM); NCT02938299 (Pivotal)

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 3 en 83 in stadium 4 (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.