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Rocapuldencel-T

Extended indication Metastatic renal cell cancer
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Rocapuldencel-T
Domain Oncology and Hematology
Main indication Kidney cancer
Extended indication Metastatic renal cell cancer
Manufacturer Argos
Route of administration Intrader meal
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
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)
Particularity New medicine
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks Fase III studie (NCT01582672)

Therapeutic value

Current treatment options Sunitinib
Therapeutic value No judgement
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.
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

Additional remarks Waarschijnlijk kostbare behandeling vergelijkbaar met andere gentherapiën.

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 NSCLC
References clinicaltrials.gov

Other information

There is currently no futher information available.