Rocapuldencel-T Medicine 12 June 2018 Extended indication Metastatic renal cell cancer Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Rocapuldencel-T Domain Oncology and Hematology Reason of inclusion Main indication Kidney cancer Extended indication Metastatic renal cell cancer Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Argos Portfolio holder Mechanism of action Unknown Route of administration Intrader meal Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Rocapuldencel-T bevat lichaamseigen dendritische cellen die genetisch worden gemanipuleerd zodat zij het imuunsysteem triggeren om de tumor op te ruimen. ADAPT-trial: T-cell responses seen. active immunotherapy. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fase III studie (NCT01582672) Therapeutic value Current treatment options Sunitinib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References clinicaltrials.gov, https://watermark.silverchair.com/ Additional remarks In de studie wordt het volgende behandelschema aangehouden: 8 injecties in het eerste jaar, gevolgd door "boosters" ieder kwartaal (bron: clinicaltrials.gov). Expected patient volume per year Patient volume < 565 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks 565 patiënten in 2016 gediagnosticeerd met stadium 4 niercarcinoom. Een deel hiervan zal in aanmerking komen voor een behandeling. Expected cost per patient per year Cost References Additional remarks Waarschijnlijk kostbare behandeling vergelijkbaar met andere gentherapiën. 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 Yes Indication extensions NSCLC References clinicaltrials.gov Additional remarks Other information Additional remarks