Masitinib Medicine 08 June 2021 Extended indication Metastatic Castration-resistant Prostate Cancer Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Masitinib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Prostate cancer Extended indication Metastatic Castration-resistant Prostate Cancer Current proprietary name Already available biosimilars / generics Proprietary name Masican Manufacturer AB Science Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen uitgebreide studieresultaten bekend. Duration of treatment Frequency of administration 2 times a day Dosage per administration 6 mg/kg/day References NCT03761225 Additional remarks 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 < 3,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, CAPRI en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom. Additional remarks 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. Het gaat hierbij om zo’n 2.400 tot 3.000 CRPC patiënten (bron: CAPRI). Gezien bijna alle patiënten met CRPC uitzaaiingen hebben is de verwachting bijna de gehele groep mCRPC patiënten betreft. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks