FDA Approves Sodium Thiosulfate to Reduce Risk for Ototoxicity Associated With Cisplatin in Kids

The FDA has approved sodium thiosulfate (Pedmark, Fennec Pharmaceuticals) to decrease ototoxicity associated with cisplatin in pediatric patients ages 1 month and older who have localized, nonmetastatic solid tumors.

Efficacy was evaluated in two multicenter, open-label, randomized controlled trials in pediatric patients undergoing treatment with cisplatin-based chemotherapy for cancer: SIOPEL 6 (ClinicalTrials.gov Identifier: NCT00652132) and COG ACCL0431 (NCT00716976).

SIOPEL 6 enrolled 114