Extended indication Extension of indication to include Keytruda as monotherapy for the adjuvant treatment of adults with
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Pembrolizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Extension of indication to include Keytruda as monotherapy for the adjuvant treatment of adults with Stage IB (T2a ≥ 4 cm), II or IIIA non-small cell lung carcinoma (NSCLC) who have undergone complete resection.
Proprietary name Keytruda
Manufacturer MSD
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 April 2022
Expected Registration February 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost < 90,000.00
References G-Standaard
Additional remarks Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2024. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.