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Venetoclax

Medicine

Extended indication Extension of indication to include, in combination with ibrutinib, the treatment of adult patients with previously untreated chronic lymphocytic leuka
Registration phase Positive CHMP opinion

Product

Active substance Venetoclax
Domain Hematology
Reason of inclusion Indication extension IND
Main indication CLL
Extended indication Extension of indication to include, in combination with ibrutinib, the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Extension of indication to include, in combination with acalabrutinib with or without obinutuzumab, the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)
Proprietary name Venclyxto
Manufacturer Janssen
Portfolio holder Janssen
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date January 2026
Expected Registration June 2026
Orphan drug No
Registration phase Positive CHMP opinion
Medicine sluice Broadly excluded
Additional remarks Positieve CHMP-opinie in april 2026.

Therapeutic value

References NCT03462719 (GLOW); NCT03836261 (AMPLIFY)

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Cost € 70,000.00 - 76,000.00

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.
References G-standaard; medicijnkosten.nl
Additional remarks AIP van €49,97 per tablet van 100mg. Op basis van SmPC en AIP zijn de kosten €70.000-€76.000 per jaar.

Potential total cost per year

Off label use

Indication extension

Other information