Toripalimab Medicine 07 June 2022 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. Therapeutic value No estimate possible yet Total cost 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. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Shanghai Junshi Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2022 Expected Registration 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion datum in april 2021. Therapeutic value Current treatment options Crizotinib, alectinib, brigatinib Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Dit geneesmiddel is op dit moment enkel op de populatie in China getest. Duration of treatment 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. Maximum patient volume for sluice 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% 249 (4). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Adisinsght Additional remarks Verschillende fase 3 studies naar: Breast cancer; Liver cancer; Neuroendocrine tumours; Renal cancer; Small cell lung cancer. Other information Additional remarks