FDA Approval Insights: Sodium Thiosulfate in Cisplatin-Treated Pediatric Solid Tumors

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Nilay Shah, MD, a physician scientist with the Center for Childhood Cancer and Blood Diseases at Nationwide Children’s Hospital and an assistant professor in the Department of Pediatrics at The Ohio State University College of Medicine, both in Columbus. Dr Shah joined us to talk about sodium thiosulfate (Pedmark) in pediatric patients with solid tumors treated with cisplatin.

On September 20, 2022, the FDA approved sodium thiosulfate in pediatric patients at least 1 month of age with localized, nonmetastatic solid tumors. The regulatory decision was based on findings from 2 phase 3 clinical trials, SIOPEL6 (NCT00652132) and COG ACCL0431 (NCT00716976), which demonstrated that the agent reduced the risk of cisplatin-associated ototoxicity.

In SIOPEL6, investigators evaluated cisplatin-based chemotherapy alone or with sodium thiosulfate in patients aged 1 month to 18 years with standard-risk hepatoblastoma. The incidence of hearing loss in patients who received the combination was 39% compared with 68% in those who received chemotherapy alone.

The COG ACCL0431 trial investigated cisplatin-based chemotherapy with or without sodium thiosulfate in patients between the ages of 1 and 18 years with newly diagnosed solid tumors, including hepatoblastoma, germ cell tumors, neuroblastoma, osteosarcoma, and medulloblastoma. The incidence of hearing loss in patients who received the combination was 44% vs 58% in those who received cisplatin alone.

In our exclusive interview, Dr Shah discussed the significance of this approval, key efficacy and safety data with sodium thiosulfate, and the importance of multidisciplinary communication when prescribing and administering the agent.

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Dr Shah would like to disclose that he has served on advisory panels for, and received a consulting remuneration from, Fennec Pharmaceuticals.