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Toripalimab

Extended indication Toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unr
Therapeutic value Possible equal value
Registration phase Registration application pending

Product

Active substance Toripalimab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (“ESCC”)
Manufacturer Shanghai Junshi
Portfolio holder 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)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2022
Expected Registration September 2024
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options Pembrolizumab
Therapeutic value Possible equal value
Substantiation In de finale analyse van de progressie-vrije survival (PFS) werd een significante verbetering van de PFS geobserveerd in de toripalimab arm ten opzichte van de placebo arm (hazard ratio [HR] = 0.58; 95% CI, 0.46-0,74; p < 0.0001). Deze studie heeft volledig plaatsgevonden in China. Recent is pembrolizumab door de cieBOM goedgekeurd. Er wordt verwacht dat toripalimab een vergelijkbare effectiviteit zal hebben.
Frequency of administration 1 times every 3 weeks
References NCT03829969, https://doi.org/10.1016/j.ccell.2022.02.007

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

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

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

Indication extension Yes
Indication extensions Meedere fase 3 studies (zie AdisInsight), nu momenteel 3 indicaties opgenomen hiervan op de Horizonscan (NSCLC, NPC en ESCC)
References Adis Insight

Other information

There is currently no futher information available.