Nivolumab/hyaluronidase Ph20

Extended indication	Second line or later treatment of advanced or metastatic clear cell renal cell carcinoma in adults and elderly who have received prior systemic therapy, monotherapy
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Nivolumab/hyaluronidase Ph20
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Kidney cancer
Extended indication	Second line or later treatment of advanced or metastatic clear cell renal cell carcinoma in adults and elderly who have received prior systemic therapy, monotherapy
Manufacturer	BMS
Mechanism of action	PD-1 / PD-L1 inhibitor
Route of administration	Subcutaneous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)
Additional remarks	Nieuwe subcutane toedieningsvorm van nivolumab met recombinant humaan hyaluronidase (rHuPH20).

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Particularity	New therapeutical formulation
ATMP	No
Submission date	June 2024
Expected Registration	July 2025
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Primary completion (estimated): 8 september 2025. Is in juni 2024 bij EMA ingediend als Extension Application. Uitgaande van gemiddelde doorlooptijden is de verwachte registratie in juli 2025.

Therapeutic value	No estimate possible yet
Substantiation	De volledige resultaten zijn nog niet bekend.
References	NCT04810078 (CheckMate-67T)

References	NKR2024 (1).
Additional remarks	In 2022 werden er 929 diagnoses niercelcarcinoom stadium III en IV gesteld (1).

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.