Active substance Seviprotimut-L
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Skin cancer
Extended indication Malignant melanoma; post-resection, stages IIb-III.


Manufacturer Polynoma
Mechanism of action Immunostimulation
Route of administration Intrader meal
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Vaccin


Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Registration phase Clinical trials
Additional comments Indien de MAVIS trial succesvol is zal er mogelijk snel een indiening volgen. Primary completion date is januari 2019.

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found
Dosage per administration 0,2 ml
Additional comments NCT01546571: "POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs".

Expected patient volume per year

References NKR
Additional comments Stadium II melanoom 950 patiënten en stadium III melanoom 419 patiënten.

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.