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Sodium Thiosulfate: Pediatric First Approval

Sohita Dhillon1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Paediatric Drugs
|December 14, 2022
PubMed

Insights

Sodium thiosulfate (Pedmark®) is a new chemoprotectant approved to prevent cisplatin-induced hearing loss in pediatric cancer patients. This antioxidant protects hearing by neutralizing cisplatin and enhancing cellular defenses against oxidative stress.

Area of Science:

  • Pharmacology and Toxicology
  • Pediatric Oncology
  • Drug Development

Background:

  • Cisplatin chemotherapy is associated with significant ototoxicity, particularly in pediatric patients.
  • Current management strategies for cisplatin-induced ototoxicity are limited.
  • Sodium thiosulfate has demonstrated chemoprotective and antioxidant properties.

Purpose of the Study:

  • To summarize the development of sodium thiosulfate (Pedmark®) as a strategy to mitigate cisplatin-induced ototoxicity.
  • To highlight the key milestones leading to the pediatric approval of sodium thiosulfate.

Main Methods:

  • Review of preclinical and clinical data on sodium thiosulfate's mechanism of action.
  • Analysis of regulatory submissions and approvals for sodium thiosulfate in pediatric populations.
  • Summary of sodium thiosulfate's interaction with cisplatin and its intracellular antioxidant effects.

Main Results:

  • Sodium thiosulfate acts as both a direct cisplatin scavenger and an intracellular antioxidant.
  • In September 2022, sodium thiosulfate (Pedmark®) received US FDA approval for pediatric patients (1 month+) with localized solid tumors.
  • Regulatory review is ongoing in the EU for similar indications in pediatric patients.

Conclusions:

  • Sodium thiosulfate represents a significant advancement in managing chemotherapy-induced ototoxicity in children.
  • The drug's dual mechanism offers a promising approach to preserve hearing during cisplatin treatment.
  • Pediatric first approval marks a critical milestone in the drug's therapeutic journey.

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