Extended indication Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance DCVAC
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Prostate cancer
Extended indication Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer.
Manufacturer Sotio
Mechanism of action Immunostimulation
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Immunostimulants

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
References NCT02111577

Expected patient volume per year

Patient volume

< 1,645

Market share is generally not included unless otherwise stated.

References bron: NKR en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom.
Additional comments Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met " cM0cNX, cM0cN0, cMcN1, cM1, pM1 " betreft 8.226 in totaal. Na starten van anti hormonale therapie zal maximaal 20% van de patiënten binnen vijf jaar CRPC ontwikkelen (1.645 patiënten). Hiervan zal een deel in aanmerking komen voor deze behandeling.

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 Yes
Indication extensions prostate cancer at various stages
References https://www.sotio.com/pipeline/dcvac-product-candidates

Other information

There is currently no futher information available.