Daratumumab

Darzalex
Active substance

Daratumumab
Domain

Oncology and Hematology
Reason of inclusion

Indication extension
Main indication

Multiple Myeloma
Extended indication 
Amyloidose eerstelijnsbehandeling in combinatie met bortezomib, cyclofosfamide en dexamethason.

Product
Proprietary name

Darzalex
Manufacturer

Janssen
Mechanism of action

Immunostimulation
Route of administration

Intravenous
Therapeutical formulation

Intravenous drip
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

September 2021
Orphan drug

Yes
Registration phase

Registration application pending

Therapeutic value
Current treatment options

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

No judgement
Duration of treatment

Not found
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

€ 109,224.00
References 
Fabrikant.
Additional comments 
Jaar 1: €109.224; Jaar 2: €61.735. Op basis van lijstprijs. Maximale behandelduur van 2 jaar.

Potential total cost per year
Total cost

€ 17,475,840

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.