Relatlimab

Extended indication	Patients With Previously Untreated Metastatic or Unresectable Melanoma in combination with nivolumab.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

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 remarks	Antibody-dependent cell cytotoxicity; T lymphocyte stimulant.

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	September 2021
Expected Registration	October 2022
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	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 estimate possible yet
References	NCT03470922

Expected patient volume per year

Patient volume	< 80 Market share is generally not included unless otherwise stated.
References	NKR
Additional remarks	Melanoom van de huid betreft 6.729 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.

Patient volume

< 80

Market share is generally not included unless otherwise stated.

References

NKR

Additional remarks

Melanoom van de huid betreft 6.729 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 remarks	Fase 2 studies

Other information

There is currently no futher information available.