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Camrelizumab

SHR-1210

Extended indication First line treatment of advanced hepatocellular carcinoma in adults and elderly, in combination with
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Camrelizumab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Liver cancer
Extended indication First line treatment of advanced hepatocellular carcinoma in adults and elderly, in combination with rivoceranib (apatinib)
Proprietary name SHR-1210
Manufacturer Jiangsu Hengrui
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Powder for injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Primary completion (actual): 8 februari 2022. De eerste topline resultaten van de CARES-310 studie zijn gebruikt voor een FDA NDA voor camrelizumab en een BLA voor camrelizumab in mei 2023. Er is echter nog geen bewijs voor een indiening bij de EMA sinds de primary completion van de studie.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Dit betreft een combinatie met een niet-geregistreerd middel in Europa. De verwachting is om deze reden dat de impact van deze nieuwe combinatie weinig impact zal hebben. De PASKWIL criteria worden gehaald.
Dosage per administration 200 mg
References NCT03764293 (CARES-310)

Expected patient volume per year

Patient volume

< 165

Market share is generally not included unless otherwise stated.
References NKR2024 (1)
Additional remarks In 2023 werden er 716 mensen gediagnosticeerd met HCC, hiervan bevonden zich er 165 in stadium IV (1).

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.