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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

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: 13 Apr 2020

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At a glance

  • Drugs Sodium thiosulfate (Primary)
  • Indications Sensorineural hearing loss
  • Focus Registrational; Therapeutic Use
  • Acronyms SIOPEL6
  • Most Recent Events

    • 13 Apr 2020 According to a Fennec media release, the company looks forward to working closely with the Agency during the review process.
    • 13 Apr 2020 According to a Fennec media release, the U.S. FDA has accepted for filing and granted Priority Review for the companys New Drug Application (NDA) for PEDMARK (a unique formulation of sodium thiosulfate), for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to <18 years of age with localized, non-metastatic, solid tumors. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 10th Aug 2020 for the completion of FDAs review.
    • 28 Feb 2020 According to a Fennec media release, Marketing Authorization Application (MAA) for its investigational drug, sodium thiosulfate (unique formulation) for infusion , has passed validation and is now under evaluation by the European Medicines Agency (EMA). MAA for Pediatric Use Marketing Authorization (PUMA) was filed in early February 2020 for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.
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