177Lu-PSMA617

Active substance 177Lu-PSMA617
Domain Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Prostate cancer
Extended indication Progressive Metastatic Castration Resistant Prostate Cancer

Product

Manufacturer Advanced Accelerator Applications
Mechanism of action Other
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments 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 Potential equal value
Substantiation 177Lu-PSMA617 wordt momenteel zelf bereid door ziekenhuizen.
Duration of treatment Not found
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 comments NCT03392428

Expected patient volume per year

References NKR
Additional comments 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 comments 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 comments Geen andere lopende fase 3 studies.

Other information

There is currently no futher information available.