Extended indication Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS).
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Eprenetapopt
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication AML / MDS
Extended indication Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS).
Manufacturer Aprea
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Apoptosis stimulant; Thioredoxin reductase inhibitor; Tumour suppressor protein p53 stimulant.

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug Yes
Registration phase Clinical trials
Additional comments Verwachte indiening op basis van primary completion datum studie in november 2020 (fase 3).

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03745716

Expected patient volume per year

References NKR
Additional comments Aantal diagnoses myelodysplastisch syndroom in 2016: 737.

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

There is currently nothing known about off label use.

Indication extension

Additional comments Geen andere fase 3 studies die nu lopen (dec 2020).

Other information

There is currently no futher information available.