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Venetoclax

Venclyxto

Extended indication

Patients With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
Therapeutic value

No estimate possible yet
Registration phase

Clinical trials

Product

Active substance

Venetoclax
Domain

Hematology
Reason of inclusion

Indication extension
Main indication

Multiple Myeloma
Extended indication

Patients With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
Proprietary name

Venclyxto
Manufacturer

Abbvie
Portfolio holder

Abbvie
Mechanism of action

Bcl-2 inhibitor
Route of administration

Oral
Therapeutical formulation

Tablet
Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)
Submission date

March 2023
Expected Registration

January 2024
Orphan drug

Yes
Registration phase

Clinical trials
Additional comments 
fase 3 studies

Therapeutic value

Therapeutic value

No estimate possible yet
Frequency of administration

1 times a day
References 
NCT03539744

Expected patient volume per year

Patient volume

< 50

Market share is generally not included unless otherwise stated.
References 
expert opinie; What Multiple Myeloma With t(11;14) Should Be Classified Into in Novel Agent Era: Standard or Intermediate Risk? Wen Gao. 2020.
Additional comments 
Deze behandeling is specifiek voor patiënten met een 11-14 mutatie. Dit komt voor bij 16-24% van de populatie, uiteindelijk is de inschatting om die reden dat niet meer dan 50 patiënten voor deze behandeling in aanmerking zullen komen.

Expected cost per patient per year

Additional comments 
De lijstprijs in de G-standaard is €5.798,58, de prijs per tablet is dus €51,77. Met vier tabletten per dag komen de kosten per maand uit op €6.212,76.

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.