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

1. 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.

2. Registration

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

3. 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.

4. 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).

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
No

9. Other information

There is currently no futher information available.