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Pembrolizumab

Medicine

Extended indication Extension of indication to include KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystect
Registration phase Registration application pending

Product

Active substance Pembrolizumab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Bladder cancer
Extended indication Extension of indication to include KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with muscle invasive bladder cancer (MIBC) who are eligible for cisplatin containing chemotherapy.
Proprietary name Keytruda
Manufacturer MSD
Portfolio holder MSD
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)
Submission date March 2026
Expected Registration February 2027
Registration phase Registration application pending

Therapeutic value

References NCT04700124

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Cost € < 90,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.
Additional remarks Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2027. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk. AIP per juni 2026: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Uitgaande van een behandeling van 1 x per 3 weken 200 mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar. Inschatting: in lijn met andere indicaties.

Potential total cost per year

Off label use

Indication extension

Other information