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Pelabresib

Extended indication Myelofibrosis
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Pelabresib
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication Myeloproliferative disorders
Extended indication Myelofibrosis
Manufacturer MorphoSys
Portfolio holder MorphoSys
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks MoA Bromodomain and extraterminal domain protein inhibitors.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
References NCT04603495
Additional remarks 1 cycle is 21 dagen waarbij dag 1-14 dagelijks wordt behandeld en dag 15-21 geen behandeling wordt gegeven.

Expected patient volume per year

References NKR (1)
Additional remarks In 2020 waren er 111 patiënten met Myelofibrosis.(1)

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

Indication extension No
References Adis Insight
Additional remarks Geen andere fase 3 studies op dit moment.

Other information

There is currently no futher information available.