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Nivolumab/relatlimab/hyaluronidase Ph20

Extended indication Patients with previously untreated metastatic or unresectable melanoma.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Nivolumab/relatlimab/hyaluronidase Ph20
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Skin cancer
Extended indication Patients with previously untreated metastatic or unresectable melanoma.
Manufacturer BMS
Mechanism of action Immunostimulation
Route of administration Subcutaneous
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
ATMP No
Submission date August 2025
Expected Registration June 2026
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
References NCT05625399
Additional remarks Het betreft een non-inferiority fase 1 studie. Er zijn nog geen resultaten bekend. De verwachting is dat de intraveneuze en subcutane toediening bio-equivalent zijn.

Expected patient volume per year

Patient volume

< 775

Market share is generally not included unless otherwise stated.
References NKR; expertopinie
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.) Het patiënten aantal is ook afhankelijk van de rol die nivolumab/relatlimab gaat krijgen.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.