Expand all sections

Lifileucel

Contego

Extended indication Maliganant melanoma, advanced melanoma
Therapeutic value No judgement
Total cost 231,350,000.00
Registration phase Clinical trials

Product

Active substance Lifileucel
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Skin cancer
Extended indication Maliganant melanoma, advanced melanoma
Proprietary name Contego
Manufacturer Iovance
Mechanism of action Autologous modified cell therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Autologe T cell therapie die gebruik maakt van tumor infiltrating lymphocytes (TILs) die uit de tumor van de patiënt zijn geïsoleerd.

Registration

Registration route Centralised (EMA)
Submission date 2020
Expected Registration 2021
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
Substantiation Maliganant melanoma is een erg competitief veld. Er worden veel cellulaire producten ontwikkeld voor dezelfde indicatie.
Duration of treatment one-off
References NCT02360579

Expected patient volume per year

Patient volume

< 661

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks 661 patiënten met Melanoom stadium III en IV

Expected cost per patient per year

Cost 300,000.00 - 400,000.00
Additional remarks Indien de resultaten van de studie positief zijn is de prijs voor een behandeling hoog. Mogelijk vergelijkbaar met CAR-T therapiën (~€300.000-400.000).

Potential total cost per year

Total cost

231,350,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.