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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.