Extended indication Metastatic Castration-resistant Prostate Cancer
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Masitinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Prostate cancer
Extended indication Metastatic Castration-resistant Prostate Cancer
Proprietary name Masican
Manufacturer AB Science
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

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

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Er zijn nog geen uitgebreide studieresultaten bekend.
Frequency of administration 2 times a day
Dosage per administration 6 mg/kg/day
References NCT03761225
Additional comments Plus docetaxel 75mg/m2 by intravenous infusion during 1 hour, once every 3 weeks (1 cycle = 21 days) for 6 cycles (8 to 10 cycles can be performed according to patient's tolerance) plus prednisone according to usual practice.

Expected patient volume per year

Patient volume

< 1,645

Market share is generally not included unless otherwise stated.

References 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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.