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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 remarks 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 remarks 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 remarks 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.