Norgine announces Swissmedic approval of Pedmarqsi for the prevention of cisplatin induced hearing loss in children

Norgine

26 March 2026 - The data from 2 open-label, randomised Phase 3 trials, SIOPEL 6 (pivotal) and the Clinical Oncology Group ACCL04313, resulted in an approximately 50% reduction in the occurrence of cisplatin-induced ototoxicity in patients treated with cisplatin and sodium thiosulfate versus those treated with cisplatin alone.

Norgine today announced that Swissmedic has granted marketing authorisation for Pedmarqsi (sodium thiosulfate solution for infusion) indicated for the prevention of cisplatin induced ototoxicity (hearing loss) in patients aged 1 month to <18 years with localised, non-metastatic solid tumours.

Read Norgine press release

Michael Wonder

Posted by:

Michael Wonder