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Daratumumab

Darzalex

Extended indication

Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the tre

Therapeutic value

No estimate possible yet
Total cost

€ 16,091,360.00
Registration phase

Registered

Product

Active substance

Daratumumab
Domain

Oncology and Hematology
Reason of inclusion

Indication extension
Main indication

Multiple Myeloma
Extended indication

Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.
Proprietary name

Darzalex
Manufacturer

Janssen
Mechanism of action

Immunostimulation
Route of administration

Subcutaneous
Therapeutical formulation

Solution for cutaneous use
Budgetting framework

Intermural (MSZ)
Additional comments 
Antilichaam tegen CD38.

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
Particularity

New therapeutical formulation
Submission date

November 2020
Expected Registration

June 2021
Orphan drug

Yes
Registration phase

Registered
Additional comments 
Positieve CHMP-opinie in mei 2021. Dit geneesmiddel is breed uitgesloten, wat betekent dat toekomstige indicaties automatisch in de sluis stromen.

Therapeutic value

Current treatment options

Bortezomib-cyclofosfamide-dexamethason of lenalidomide-dexamethason.
Therapeutic value

No estimate possible yet
Dosage per administration

16mg/kg
References 
NCT03201965.
Additional comments 
Daratumumab zal wekelijks worden toegediend in de eerst 8 weken (2 cycli), daarna iedere 2 weken voor 4 cycli (cyclus 3-6) en daarna iedere 4 weken tot progressie of een maximum van 2 jaar. Jaar 1: 23 toedieningen; jaar 2: 13 toedieningen. Maximale behandelduur van 2 jaar.

Expected patient volume per year

Patient volume

< 160

Market share is generally not included unless otherwise stated.
References 
De behandeling van AL-amyloïdose in Nederland anno 2013, HOVON;
Additional comments 
De incidentie wordt geschat op 8,9 per miljoen persoonsjaren; dat betekent dat er in Nederland 160 nieuwe patiënten per jaar zijn.

Expected cost per patient per year

Cost

< € 100,571.00
References 
Fabrikant, G-standaard
Additional comments 
Jaar 1: €100.571; Jaar 2: €56.845. Op basis van lijstprijs. Maximale behandelduur van 2 jaar.

Potential total cost per year

Total cost

€ 16,091,360.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension

Yes
Indication extensions

In fase 3 klinische studies: Relapsed Refractory MM 1+ prior lines w/PomDex; Relapsed Refractory multiple myeloma w/carfilzomib/dex; Amyloidosis; Subcutaneous Formulation in patients with relapsed or refractory multiple myeloma; Smoldering multiple myeloma; Frontline multiple myeloma transplant ineligible in combination w/ bortezomib, lenalidomide and dexamethasone; Frontline multiple myeloma transplant eligible in combination w/ bortezomib, lenalidomide and dexamethasone.
References 
Pipeline Janssen.

Other information

There is currently no futher information available.