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

Product

Active substance Toripalimab
Domain Oncology
Reason of inclusion New medicine (specialité)
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

Registration route Centralised (EMA)
Submission date 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials
Additional comments 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 comments 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 comments 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% 249 (4).

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

References Adisinsght
Additional comments 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.