Sodium thiosulfate

Active substance
Sodium thiosulfate
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Other oncology
Extended indication
Preventing Hearing Loss in Young Patients (1 year to 18 years old) receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy.

1. Product

Proprietary name
Pedmark
Manufacturer
Fennec Pharmaceuticals
Mechanism of action
Antioxidant
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Extramural (GVS)

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
March 2020
Expected Registration
April 2021
Orphan drug
No
Registration phase
Registration application pending

3. Therapeutic value

Therapeutic value
No judgement
Substantiation
De effectiviteit van sodium thiosulfaat op het voorkomen van ototoxiciteit is aangetoond middels onderzoek. Daarentegen is ook aangetoond dat sodium thiosulfaat de effectiviteit van cisplatine mogelijk teniet doet (Freyer, 2014). De algehele survival van de groep patiënten die sodium thiosulfaat is namelijk kleiner dan dat van de controle groep.
Duration of treatment
Not found
Dosage per administration
16 g/m2
References
NCT00716976, Freyer, D. (2014). The effects of sodium thiosulfate (STS) on cisplatin-induced hearing loss: A report from the Children’s Oncology Group. Journal Of Clinical Oncology, 32(15_suppl), 10017-10017.
Additional comments
Dosering per toediening: 16 g/m2 or 533 mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body)

4. Expected patient volume per year

Additional comments
De inschatting in de leeftijdscategorie van 1 tot 18 is dat er maximaal 500 patiënten voor in aanmerking zullen komen.

5. Expected cost per patient per year

References
https://dawsonjames.com/
Additional comments
In een equity onderzoek van DawsonJames securities wordt een prijs van $60.000 genoemd, ongeveer €54.000.

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
adisinsight

9. Other information

There is currently no futher information available.