Seviprotimut-L

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

1. Product

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

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
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.

3. 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."

4. Expected patient volume per year

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

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.