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177Lu-PSMA617

Extended indication

Progressive Metastatic Castration Resistant Prostate Cancer
Therapeutic value

Possible equal value
Registration phase

Clinical trials

Product

Active substance

177Lu-PSMA617
Domain

Oncology and Hematology
Reason of inclusion

New medicine (specialité)
Main indication

Prostate cancer
Extended indication

Progressive Metastatic Castration Resistant Prostate Cancer
Manufacturer

Advanced Accelerator Applications
Mechanism of action

Other
Route of administration

Intravenous
Therapeutical formulation

Injection
Budgetting framework

Intermural (MSZ)
Additional remarks 
Radioligand

Registration

Registration route

Centralised (EMA)
Submission date

2021
Expected Registration

2022
Orphan drug

No
Registration phase

Clinical trials

Therapeutic value

Current treatment options

177Lu-PSMA617
Therapeutic value

Possible equal value
Substantiation

177Lu-PSMA617 wordt momenteel zelf bereid door ziekenhuizen.
Frequency of administration

1 times every 6 weeks
Dosage per administration

6-8.5GBq
References 
The first dose will be administered at 8.5GBq, reducing by 0.5GBq with every cycle given (i.e. to 6.0GBq on the sixth cycle, if reached)
Additional remarks 
NCT03392428

Expected patient volume per year

References 
NKR
Additional remarks 
2.302 diagnoses prostaatkanker stadium 4 in 2015. 75% van deze patiënten ontwikkelt CRCP (n=1.727).

Expected cost per patient per year

Cost

83,000.00
References 
Horizonscan Geneesmiddelen Lutathera
Additional remarks 
De kosten zullen waarschijnlijk vergelijkbaar zijn met Lutetium (177Lu) oxodotreotide € 83.000.

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

Indication extension

No
References 
clinicaltrials.gov
Additional remarks 
Geen andere lopende fase 3 studies.

Other information

There is currently no futher information available.