Extended indication

Patients With Previously Untreated Metastatic or Unresectable Melanoma in combination with nivolumab.

Therapeutic value

No judgement

Registration phase

Clinical trials

Product

Active substance

Relatlimab

Domain

Oncology and Hematology

Reason of inclusion

New medicine (specialité)

Main indication

Skin cancer

Extended indication

Patients With Previously Untreated Metastatic or Unresectable Melanoma in combination with nivolumab.

Manufacturer

BMS

Mechanism of action

Immunostimulation

Route of administration

Intravenous

Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)

Additional comments
Antibody-dependent cell cytotoxicity; T lymphocyte stimulant.

Registration

Registration route

Centralised (EMA)

Submission date

2021

Expected Registration

November 2022

Registration phase

Clinical trials

Additional comments
De fabrikant verwacht registratie in het vierde kwartaal van 2022.

Therapeutic value

Current treatment options

Pembrolizumab, nivolumab, ipilimumab, dabrafenib/trametinib, encorafenib/binimetinib, vemurafenib/cobimetinib.

Therapeutic value

No judgement

References
NCT03470922

Expected patient volume per year

Patient volume

< 80

Market share is generally not included unless otherwise stated.

References
NKR
Additional comments
Melanoom van de huid betreft 6729 patiënten in 2018, hiervan zijn er 541 patiënten met stadium 3 en 203 patiënten met stadium 4 (maximaal 744 patiënten die in aanmerking komen voor deze behandeling.) Hiervan zijn zo'n 80 patiënten behandeld met nivolumab, dit lijkt de meest waarschijnlijke groep waar dit middel ingezet gaat worden.

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

Indication extension

Yes

Indication extensions

Acute myeloid leukaemia; Colorectal cancer; Gastric cancer; Head and neck cancer; Non-small cell lung cancer; Renal cell carcinoma; Soft tissue sarcoma; Solid tumours.

References
Adisinsight.
Additional comments
Fase 2 studies

Other information

There is currently no futher information available.