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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jun 2023

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At a glance

  • Drugs Sodium thiosulfate (Primary)
  • Indications Sensorineural hearing loss
  • Focus Registrational; Therapeutic Use
  • Sponsors Fennec Pharmaceuticals
  • Most Recent Events

    • 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
    • 31 Mar 2023 According to a Fennec Pharmaceuticals media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion and recommended granting a Marketing Authorization for Pedmarqsi for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localized, non-metastatic, solid tumors, based on SIOPEL 6 and Clinical Oncology Group [COG] Protocol ACCL0431.
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