A Multi-centre Open-label Randomised Phase III Trial of the Efficacy of Sodium Thiosulphate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma
Latest Information Update: 26 Mar 2024
At a glance
- Drugs Sodium thiosulfate (Primary)
- Indications Sensorineural hearing loss
- Focus Registrational; Therapeutic Use
- Sponsors Fennec Pharmaceuticals
- 01 Oct 2023 According to a Fennec Pharmaceuticals media release, the company received approval from the MHRA in UK for PEDMARK (sodium thiosulfate injection).
- 06 Jun 2023 According to a Fennec Pharmaceuticals media release, the company received marketing authorization by the European Commission for Pedmarqsi (sodium thiosulfate) in pediatric patients with localized, non-metastatic solid tumors, based on SIOPEL 6 and Clinical Oncology Group [COG] Protocol ACCL0431). The marketing authorization is applicable to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein.
- 31 Mar 2023 According to a Fennec Pharmaceuticals media release, ratification of the CHMP recommendation is expected by early June 2023