Expand all sections

Leukocyte interleukin

Multikine

Extended indication Cancer of the oral cavity, neoadjuvant
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Leukocyte interleukin
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Head and neck cancer
Extended indication Cancer of the oral cavity, neoadjuvant
Proprietary name Multikine
Manufacturer CEL-SCI
Route of administration Local
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Multikine is a mixture of naturally occurring cytokines that regulate the immune system.

Registration

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

Therapeutic value

Current treatment options Chirurgie gevolgd door radiotherapie en mogelijk chemotherapie.
Therapeutic value No estimate possible yet
Substantiation De behandeling lijkt wel een positief effect te kunnen hebben. Op dit moment is het product nog lastig te duiden. Het is namelijk niet vergelijkbaar met andere immunotherapie. Uit de klinische studie blijkt dat LI immunotherapie niet leidt tot extra veiligheidsrisico's. Een vroege LI respons verlaagde de mortaliteit. Er werd een winst in overall survival gevonden wanneer LI + SOC gegeven werd in plaats van enkel SOC 0.68 HR.
Duration of treatment Average 3 week / weeks
Frequency of administration 1 times a day
References NCT01265849

Expected patient volume per year

Patient volume

< 235

Market share is generally not included unless otherwise stated.
References IKNL 2021
Additional remarks Het aantal diagnoses van patiënten in 2021 in Nederland die aan de selectiecriteria voldoen van de klinische studie (oral cavity (anterior tongue, floor of mouth, cheek)/soft palate, categories T1N1-2M0,T2N1-2M0,T3N0-2M0,T4N0-2M0) bedraagt 235.

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.