Leukocyte interleukin

Active substance Leukocyte interleukin
Domain Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Head and neck cancer
Extended indication Head and neck (or upper airways tract) cancers, squamous cell - first-line

Product

Proprietary name Multikine
Manufacturer Teva
Mechanism of action Immunostimulation
Route of administration Peritumoral
Budgetting framework Intermural (MSZ)
Additional comments Immunotherapie die zowel actieve als passieve immuunactiviteit biedt en wordt toegediend voorafgaand aan andere therapie waaronder ook chirurgie of radiotherapie.

Registration

Registration route Centralised (EMA)
Submission date 2020
Expected Registration 2021
Registration phase Clinical trials
Additional comments Orphan status bij de FDA

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found
Frequency of administration 1 times a day
Dosage per administration 200 mL
References NCT01265849
Additional comments In de klinische trial IT-MATTERS: LI 400IU (2.0mL per dag, 1.0 mL peritumoral, 1.0 mL perilymphatic) wordt 5 maal per week toegediend, gedurende 3 weken.

Expected patient volume per year

Patient volume

160

Market share is generally not included unless otherwise stated.

References NKR; IT-MATTERS trial
Additional comments Er zijn in totaal 2.855 met SCC van het hoofd-halsgebied. 375 hiervan hebben stadium III en 1.015 stadium IV. In totaal dus 1.390 met stadium III/IV. Schatting op basis van IT-MATTERS-inclusiecriteria (SCC oral cavity or soft palate with clinical stage III & IVA): 354 patiënten per jaar. Van deze groep worden er momenteel 160 patiënten per jaar behandeld met de huidige SOC (chirurgie met (C)RT).

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

Other information

There is currently no futher information available.