Extended indication 2L ESCC (esophageal squamous-cell carcinoma)
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Tislelizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Head and neck cancer
Extended indication 2L ESCC (esophageal squamous-cell carcinoma)
Manufacturer Novartis
Portfolio holder Novartis
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2022
Expected Registration May 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options OVerige PD/PDL-1 remmers
Therapeutic value No estimate possible yet
Substantiation De fase III (RATIONALE 302) vergelijkt chemotherapie met tislelizumab. Dit zorgde voor een significante verbetering van de mediane overall survival (8.6 maanden versus 6.3 maanden; HR = 0.70; P = .0001). Het is onduidelijk of deze resultaten voldoende zijn voor uiteindelijke goedkeuring.
References Ajani J, El Hajbi F, Cunningham D, et al: Randomized phase III study of second-line tislelizumab vs chemotherapy in advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302)

Expected patient volume per year

References NKR2018
Additional comments Aantal patiƫnten met slokdarmcarcinoom stadium I, II, III was in 2018 2.116.

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

Off label use No

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.