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 comments
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.