Extended indication Pembrolizumab in combination with definitive chemoradiotherapy for first line treatment of oesophageal carcinoma in adults and elderly who are ineligi
Registration phase Clinical trials

Product

Active substance Pembrolizumab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Oncology other
Extended indication Pembrolizumab in combination with definitive chemoradiotherapy for first line treatment of oesophageal carcinoma in adults and elderly who are ineligible for curative surgery.
Proprietary name Keytruda
Manufacturer MSD
Portfolio holder MSD
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Concentrate for solution for injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date May 2027
Expected Registration December 2027
Orphan drug No
Registration phase Clinical trials
Medicine sluice Out of the sluice
Additional remarks Voor alle indicaties van pembrolizumab geldt een financieel arrangement tot 1 januari 2027.

Therapeutic value

References NCT04210115 (KEYNOTE-975)

Expected patient volume per year

Patient volume 304

Market share is generally not included unless otherwise stated.

References https://iknl.nl/rapport-slokdarm-en-maagkanker-2024/slokdarmkanker

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information