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

1. Product

Manufacturer
Advanced Accelerator Applications
Mechanism of action
Other
Route of administration
Intravenous
Therapeutical formulation
Injection
Budgetting framework
Intermural (MSZ)
Additional comments
Radioligand

2. Registration

Registration route
Centralised (EMA)
Submission date
2021
Expected Registration
2022
Orphan drug
No
Registration phase
Clinical trials

3. 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

4. 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).

5. Expected cost per patient per year

Cost
83,000
References
Horizonscan Geneesmiddelen Lutathera
Additional comments
De kosten zullen waarschijnlijk vergelijkbaar zijn met Lutetium (177Lu) oxodotreotide € 83.000.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
No
References
clinicaltrials.gov
Additional comments
Geen andere lopende fase 3 studies.

9. Other information

There is currently no futher information available.