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Seviprotimut-L

Extended indication Malignant melanoma; post-resection, stages IIb-III.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

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 remarks Vaccin

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional remarks Indien de MAVIS trial succesvol is zal er mogelijk snel een indiening volgen. Primary completion date is januari 2019.

Therapeutic value

Therapeutic value No estimate possible yet
Dosage per administration 0,2 ml
Additional remarks NCT01546571: "POL-103A is administered intradermally, divided into 4 injections (0.2mL each injection) into the volar surface of forearms and into the anterior upper thighs".

Expected patient volume per year

References NKR
Additional remarks 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.