FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in paediatric patients with localised, non-metastatic solid tumours

FDA

20 September 2022 - Today, the FDA approved sodium thiosulphate (Pedmark, Fennec Pharmaceuticals) to reduce the risk of ototoxicity associated with cisplatin in paediatric patients one month and older with localised, non-metastatic solid tumours.

Efficacy was evaluated in two multi-centre open-label, randomised controlled trials in paediatric patients undergoing treatment with cisplatin-based chemotherapy for cancer: SIOPEL 6 and COG ACCL043.

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Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Paediatrics