Extended indication 1L locally advanced or metastatic ESCC (esophageal squamous-cell carcinoma)
Therapeutic value No estimate possible yet
Registration phase Registration application pending


Active substance Tislelizumab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication 1L locally advanced or metastatic ESCC (esophageal squamous-cell carcinoma)
Manufacturer BeiGene
Portfolio holder BeiGene
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Injection / infusion solution
Budgetting framework Intermural (MSZ)
Additional remarks Precieze indicatie is nog onbekend


Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2023
Expected Registration 2024
Orphan drug Yes
Registration phase Registration application pending
Additional remarks Nog niet ingediend bij EMA

Therapeutic value

Current treatment options Chemotherapie en PD-1/PD-L1 inhibitors plus chemotherapie.
Therapeutic value No estimate possible yet
Substantiation De mediane algehele overleving was 17,2 maanden met tislelizumab plus chemotherapie en 10,6 maanden met enkel chemotherapie (HR= 0,66; P<.0001). De cieBOM heeft in mei 2022 pembrolizumab + chemotherapie studie (KEYNOTE-590-studie) goedgekeurd voor de eerstelijn. De verwachting is dat tislelizumab vergelijkbaar zal zijn en de concurrentie zal aangaan met deze pd-l1 remmer.
Frequency of administration 1 times every 3 weeks
Dosage per administration 1
References Yoon et al. 2022
Additional remarks Betreft klinische studie RATIONALE-306

Expected patient volume per year

References NKR 2021
Additional remarks In 2021 zijn in Nederland 1.787 patiënten met stadium III en IV slokdarmkanker gediagnosticeerd.

Expected cost per patient per year

References Cost-effectiveness analysis of tislelizumab, nivolumab and docetaxel as second- and third-line for advanced or metastatic non-small cell lung cancer in China. Front Pharmacol. 2022 Aug 25.
Additional remarks De prijs in Nederland is nog niet bekend. In een kosteneffectiviteit studie bij longkanker lijkt de prijs per patiënt wel lager uit te vallen dan bij bijvoorbeeld de PD-L1 remmer nivolumab.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension Yes
Indication extensions Verschillende klinische studies lopen binnen longkanker en gastro-intestinale tumortypes

Other information

There is currently no futher information available.