Tavokinogene telseplasmid Medicine 10 December 2019 Extended indication Patients with stage III/IV metastatic melanoma who have failed or are failing on anti-PD-1 therapies (like nivolumab and pembrolizumab) in combination with pembrolizumab. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Tavokinogene telseplasmid Domain Oncology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Patients with stage III/IV metastatic melanoma who have failed or are failing on anti-PD-1 therapies (like nivolumab and pembrolizumab) in combination with pembrolizumab. Current proprietary name Already available biosimilars / generics Proprietary name Tavo Manufacturer OncoSec Portfolio holder Mechanism of action Immunostimulation Route of administration Intratumoral Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Tavokinogene telsaplasmid codeert voor IL-12, een immunostimulant. Electroporatie via ImmunoPulse is benodigd voor de activatie van tavokinogene telsaplasmid in het tumorweefsel. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Yes Submission date September 2022 Expected Registration October 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Heeft een wees status bij de FDA. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03132675 Additional remarks Patiënten worden behandeld met intratumorale tavo-EP op dag 1, 5 en 8 iedere 6 weken en met intraveneuze toediening van pembrolizumab (200mg) op dag 1 van iedere 3-weekse cyclus gedurende 17 tavo-EP cycli en 33 pembrolizumab cycli. Expected patient volume per year Patient volume < 775 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Melanoom van de huid betreft 6.746 patiënten in 2020, hiervan zijn er 687 patiënten met stadium 3 en 88 patiënten met stadium 4 (maximaal 775 patiënten die in aanmerking komen voor deze behandeling.) 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 Yes Indications off label use References OncoSec pipeline Additional remarks Indication extension Indication extensions No Indication extensions References adisinsght Additional remarks Geen lopende fase 3 studies. Other information Additional remarks