Extended indication Patients with advanced non-small cell lung cancer without activated EGFR mutation (exon 19 deletion,
Therapeutic value No estimate possible yet
Total cost 24,960,000.00
Registration phase Clinical trials


Active substance Toripalimab
Domain Oncology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Patients with advanced non-small cell lung cancer without activated EGFR mutation (exon 19 deletion, or exon 21 L858R, exon 21 L861Q, exon 18 G719X or exon 20 S768I mutations) and ALK fusion in combiantion With Chemotherapy.
Manufacturer Shanghai Junshi
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)


Registration route Centralised (EMA)
Submission date 2024
Expected Registration 2025
Orphan drug No
Registration phase Clinical trials
Additional remarks Primary completion datum in april 2021.

Therapeutic value

Current treatment options Crizotinib, alectinib, brigatinib
Therapeutic value No estimate possible yet
Substantiation Dit geneesmiddel is op dit moment enkel op de populatie in China getest.
Frequency of administration 1 times every 3 weeks
Dosage per administration 240mg/6ml
References NCT03856411
Additional remarks 240mg/6ml/vial, Q3W.

Expected patient volume per year

Patient volume

249 - 999

Market share is generally not included unless otherwise stated.

References NKR 2018 (1); American Cancer Society (2); Pakketadvies Atezolizumab (3); Expertopinie (4)
Additional remarks Jaarlijks presenteren er ongeveer 5.062 patiënten per jaar met NSCLC stadium IV (1). Ongeveer 47% van deze patiënten heeft een niet-plaveiselcelcarcinoom 2.379 (2). Hiervan ontvangt 60% een eerstelijnsbehandeling (1.427) waarvan 70% chemotherapie 999 (3). Gezien de overige behandelopties met immuuntherapie in de eerste lijn zal er slechts een deel van de patiënten voor deze behandeling in aanmerking komen. Er wordt hiervoor uitgegaan van 25% dat komt neer op 249 patiënten (4).

Expected cost per patient per year

Cost 30,000.00 - 50,000.00
References GIP databank
Additional remarks Mogelijk vergelijkbaar met andere PD1 remmers

Potential total cost per year

Total cost


This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

References Adisinsght
Additional remarks Verschillende fase 3 studies naar: Breast cancer; Liver cancer; Neuroendocrine tumours; Renal cancer; Small cell lung cancer.

Other information

There is currently no futher information available.