Nemvaleukin alfa

Extended indication	Nemvaleukin alfa monotherapy for second line treatment of unresectable and/or metastatic mucosal melanoma in adults and elderly who have previously received anti-PD-L1 therapy
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Nemvaleukin alfa
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Skin cancer
Extended indication	Nemvaleukin alfa monotherapy for second line treatment of unresectable and/or metastatic mucosal melanoma in adults and elderly who have previously received anti-PD-L1 therapy
Manufacturer	Mural Oncology
Route of administration	Intravenous
Therapeutical formulation	Injection
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	June 2025
Expected Registration	July 2026
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Indieningsdatum en verwachte registratie op basis van IHSI-inschatting.

Therapeutic value

Current treatment options	Er is nog geen huidige behandeling.
Therapeutic value	No estimate possible yet
Substantiation	Op dit moment loopt de ARTISTRY-6 studie nog. De resultaten dienen afgewacht te worden. Aangezien er nog geen behandeling is zou het mogelijk wel een aanwinst kunnen zijn.
References	NCT04830124 (ARTISTRY-6)

Expected patient volume per year

Patient volume	< 110 Market share is generally not included unless otherwise stated.
References	NKR 2022 (1); MedNet (2).
Additional remarks	In 2022 waren er ongeveer 1.100 diagnoses melanoom, stadium III en IV (1). De incidentie van mucosale melanomen, is ongeveer 1% van alle gevallen van melanoom (2). Het patiëntvolume is afhankelijk van het aantal gebruikers van anti-PD-L1 therapie binnen deze groep.

Patient volume

< 110

Market share is generally not included unless otherwise stated.

References

NKR 2022 (1); MedNet (2).

Additional remarks

In 2022 waren er ongeveer 1.100 diagnoses melanoom, stadium III en IV (1). De incidentie van mucosale melanomen, is ongeveer 1% van alle gevallen van melanoom (2). Het patiëntvolume is afhankelijk van het aantal gebruikers van anti-PD-L1 therapie binnen deze groep.

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.