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Sodium thiosulfate

Pedmark

Extended indication Preventing Hearing Loss in Young Patients (1 year to 18 years old) receiving Cisplatin for Newly Dia
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Sodium thiosulfate
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
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.
Proprietary name Pedmark
Manufacturer Fennec Pharmaceuticals
Mechanism of action Antioxidant
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Extramural (GVS)

Registration

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

Therapeutic value

Therapeutic value No estimate possible yet
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.
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 remarks Dosering per toediening: 16g/m2 or 533mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body).

Expected patient volume per year

Patient volume

< 500

Market share is generally not included unless otherwise stated.
Additional remarks De inschatting in de leeftijdscategorie van 1 tot 18 is dat er maximaal 500 patiënten voor in aanmerking zullen komen.

Expected cost per patient per year

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

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 adisinsight

Other information

There is currently no futher information available.