On September 20, 2022, the #FDA approved #sodium_thiosulfate to reduce the risk of #ototoxicity associated with #cisplatin in pediatric patients (aged ≥ 1 month) with localized, nonmetastatic solid tumors.

The approval was based on SIOPEL 6 and COG ACCL0431 trials. In both, a total of 191 pediatric patients were randomly assigned to receive cisplatin-based chemotherapy with or without intravenous (IV) sodium thiosulfate administered at the recommended body weight–based doses. In SIOPEL 6, the primary endpoint was grade ≥ 1 hearing loss on the Brock scale, assessed after treatment or at age ≥ 3.5 years. Hearing loss occurred in 39% vs 68% of patients with vs without sodium thiosulfate (Relative risk = 0.58, 95% CI= 0.40–0.83).

In COG ACCL0431, the primary endpoint was hearing loss, based on American Speech-Language-Hearing Association criteria at 4 weeks after the final course of cisplatin. Hearing loss occurred in 44% vs 58% (Relative risk = 0.75, 95% CI = 0.48–1.18).